Med Communications International

Role Description The Senior Regulatory Writing Specialist is a professional responsible for the creation of regulatory materials for investigational and marketed products in alignment with regulatory and compliance practices. The individual will work directly with client teams to manage regulatory writing projects. Qualifications - 3+ years of regulatory writing experience (actual writing, not just a contributor) - Experience with at least 3 different regulatory documents (including but not limited to: clinical study reports, protocols, Investigators Brochures, briefing documents, Module 2 documents) - Client-facing experience/project management experience - Excellent attention to detail - MS Word expertise - Experience with quality control (QC) review - Fluent in English (C1 or C2) - Clinical regulatory experience Requirements - Regulatory writing skills with mastery of 3 or more regulatory document types (e.g., clinical study protocols, clinical study reports, briefing documents, IND, NDA, and MAA components) - Solid understanding of and ability to apply statistical, regulatory, and medical communication concepts needed to independently write regulatory documents in more than 1 therapeutic area - Manages at least 3 single-document projects simultaneously - Working knowledge of relevant regulatory guidance (e.g., ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance - Acts as a primary writer and/or project manager for key documents and projects - Ensures document accuracy, completeness, and consistency of messaging - Organizes and leads cross-functional document review meetings, clarifies and incorporates feedback - Works with cross-functional subject matter experts to resolve unclear comments and differences of opinion between functional areas - Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) and writer peer review (logical flow, sense check, etc.) - Leads project-level management activities, i.e., timeline preparation and oversight and meeting scheduling - Participates in guiding less experienced writers on those documents for which they have expertise - Proactively contributes to improvements to medical writing processes - Understands, complies with, and contributes to the updates of SOPs, templates, best practices, policies, and regulatory writing style guides - Develops project-level lexicons and conventions Benefits - Remote work opportunity - Location: Remote Brazil Company Description We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.

Role Description The Pharmacovigilance Project Manager / Project Lead is a senior client-facing professional responsible for the end-to-end operational management of one or more assigned pharmacovigilance client accounts at Med Communications. The role serves as the primary interface between the client and the MC PV team, ensuring the timely, high-quality, and fully compliant delivery of all contracted pharmacovigilance services across case management, periodic reporting, signal detection, risk management, and related regulatory activities. Operating at a senior level within the PV department, the PV Project Manager / Project Lead combines strong scientific and regulatory knowledge with exceptional project management, communication, and stakeholder management capabilities. The role does not carry direct line management responsibility but exercises functional oversight of PV Specialists and Sr. PV Specialists assigned to the project, coordinating their workload, guiding their day-to-day activities, and supporting their professional development within the context of the client engagement. The role reports directly to the Global Head of Pharmacovigilance and Drug Safety. Essential Functions - Client and Account Management: - Serve as the primary point of contact for all communications between the client and the MC PV team, ensuring professional, accurate, and timely responses to all client enquiries and requests. - Build and maintain a strong, trust-based relationship with client stakeholders, including the client's pharmacovigilance, regulatory, medical, and quality teams, as applicable. - Coordinate, schedule, and lead regular client meetings, teleconferences, and governance reviews; prepare agendas, minutes, and action items and ensure timely follow-up on all open items. - Immediately escalate to the Global Head of PV and PVQM any breach in normal execution of contracted activities, service-level deviations, or issues that could impact the client's regulatory compliance position. - Identify opportunities for additional services or expanded scope within existing client engagements and communicate these to the Global Head of PV. - Coordinate the onboarding of new clients or new product additions, including the organisation of training curricula, implementation plans, and system access for the assigned PV team, in collaboration with the PVQM. - Operational Project Management: - Oversee and coordinate the day-to-day PV activities of the assigned project team — including case processing, literature review, periodic and aggregate reporting, signal detection, and risk management — ensuring all activities are executed in compliance with applicable SOPs, client-specific procedures, and regulatory requirements (EMA GVP, ICH, FDA, UK MHRA, and others as applicable). - Plan, monitor, and adjust resource allocation across the assigned project team to ensure adequate coverage, equitable workload distribution, and consistent delivery of contracted service levels. - Maintain and regularly update project documentation, tracking tools, and network files to ensure completeness, accuracy, and accessibility for all relevant team members. - Monitor project-level metrics and Key Performance Indicators (KPIs), identify trends or risks, and proactively implement corrective measures in collaboration with the Global Head of PV. - Coordinate directly with the PVQM and relevant internal stakeholders regarding any updated client operational procedures, regulatory changes, or system modifications requiring team training or process updates. - Communicate and ensure integration of PV activities with key stakeholders for the client, including the PV Physician, the Qualified Person Responsible for Pharmacovigilance (QPPV), and other relevant parties. - Collaborate with other MC departments — including Medical Information, Quality, IT, and Finance — as required to deliver seamless service to the client. - Functional Team Oversight and Development: - Exercise functional oversight of PV Specialists and Sr. PV Specialists assigned to the project, providing day-to-day guidance on task prioritisation, follow-up handling, and adherence to client procedures, without holding formal line management accountability. - Coordinate the development and delivery of training curricula and onboarding plans for newly assigned team members, ensuring all required training is documented and completed prior to task initiation, in collaboration with the PVQM. - Mentor and coach team members on PV operations, client expectations, and professional best practices, fostering a culture of accuracy, accountability, and continuous improvement. - Provide input to the Global Head of PV on team performance, development needs, staffing requirements, and resource planning for the assigned client portfolio. - Scientific and Regulatory Contribution: - Maintain a thorough working knowledge of relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), EMA GVP Modules, FDA requirements, and UK MHRA guidance, applying this knowledge to ensure the regulatory integrity of all project deliverables. - Liaise with the PV Physicians and PVMW Manager or other relevant functions, as applicable, for scientific information exchange pertaining to case assessments, signal evaluation outcomes, and benefit-risk implications relevant to the client's products. - Support the role of the QPPV in relation to regulatory reporting obligations and safety communications as required by the client engagement. - Regularly attend process or product training sessions to maintain awareness of and knowledge of relevant regulatory and scientific updates. - Quality and Compliance: - Maintain inspection and audit readiness for all assigned project activities at all times; actively support Quality Assurance in internal and external audits, including preparation, hosting, and CAPA follow-up. - Collaborate with the PV Quality Manager (PVQM) and other quality roles to ensure applicable SOPs are executed as required across the assigned project team. - Monitor compliance against project and departmental goals; identify and report deviations from procedures and collaborate in the development, implementation, and timely closure of Corrective and Preventive Actions (CAPAs). - Provide regular compliance status reports to the Global Head of PV and PVQM and, where required, to the client. - Create, review, and provide feedback on Quality Management System documents in collaboration with the Global Head of PV and the PVQM. - Identify opportunities for process improvement and efficiency across PV operations and contribute to the development, implementation, and maintenance of optimised procedures. - Participate in or lead process improvement initiatives related to automation, system upgrades, or integration of safety systems as applicable. - Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements. - Perform other pharmacovigilance activities as requested. Qualifications - Excellent working knowledge of relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), GCP, GVP Modules, and applicable regulatory requirements across EU, US, and UK jurisdictions. - Demonstrated ability to plan, prioritise, and coordinate multiple concurrent client activities and deliverables across a cross-functional team, within a regulated environment. - Proven ability to represent MC professionally, manage client expectations, and build productive, long-term working relationships with client stakeholders at all levels. - Ability to provide functional direction, motivate, and develop a project team without formal line management authority; strong influencing and negotiation skills. - Ability to accept responsibility and account for his/her actions and those of the project team within the scope of the engagement. - Ability to perform work accurately and thoroughly, maintaining high standards of quality in a regulated, deadline-driven environment. - Ability to assess complex operational and regulatory situations, identify root causes, and drive resolution. - Ability to pay close attention to the details of project deliverables, compliance documentation, and client communications. - Ability to identify and proactively address operational, regulatory, and relationship challenges. - Ability to actively attend to, convey, and understand the comments and questions of clients, team members, and internal stakeholders. - Ability to communicate clearly and concisely in writing across a range of formats including client correspondence, project plans, compliance reports, and SOPs. - Ability to communicate complex PV and project management matters effectively to diverse internal and external audiences. - Ability to address client needs while adhering to MCI's procedures, standards, and quality requirements. - Ability to work with initiative, manage competing priorities, and drive outcomes independently in a fast-paced, matrixed environment. - Possesses the trait of being well organised and following systematic methods of managing project activities, documentation, and communications. - Ability to complete assigned tasks and maintain quality standards under stressful conditions and tight regulatory timelines. - Ability to conform to a set of values and accepted standards; maintains the highest levels of integrity in all client and regulatory interactions. - Demonstrated ability to work effectively in a matrix environment. - Fluent in English; proficiency in additional languages is an advantage. Skills and Abilities - Advanced degree in life sciences (PharmD or MD preferred), or a relevant equivalent combination of education and pharmacovigilance experience. - Minimum of five years of pharmacovigilance experience, including at least two years in a project management, project lead, or client-facing account management role at a PV vendor, CRO, or pharmaceutical company. - Demonstrated ability to manage complex, multi-product client accounts across multiple PV domains (case management, periodic reporting, signal detection, risk management) is required. - Experience with drugs, biologics, vaccines, and/or devices is preferred. - Proficiency with safety databases (Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), and project management or tracking tools required. - Familiarity with literature search platforms (Embase, OvidPV, PubMed) and document management systems is an advantage. - Working knowledge of global legal, regulatory, and compliance requirements applicable to pharmacovigilance across multiple jurisdictions (EU, US, UK, ICH). - Experience supporting or managing regulatory agency interactions and audit/inspection preparation is preferred.

Role Description The (Senior) Medical Writer - Scientific Communications Specialist is a professional with scientific, clinical, and therapeutic area expertise, responsible for oversight of staff and client services. The position also provides scientifically accurate and balanced information to internal stakeholders, external healthcare professionals, and consumers in a way that supports business needs; is aligned with regulatory and compliance practices; and is consistent with Medical Affairs and brand team objectives. Essential Functions - Develop and review content for scientific documents including standard and custom responses, slide decks, dossiers, manuscripts, and other deliverables requested by the client. - Demonstrate ongoing scientific expertise relevant to therapeutic areas, including products, disease state management, and emerging therapies. - Integrate scientific expertise with knowledge of regulatory and compliance guidelines to ensure comprehensive review of materials submitted into approval process. - Create and/or review medical affairs materials and promotional materials. - Apply approved standards of style to created and maintained materials. - Demonstrate proficiency in the use of content management systems as applicable. - Update Standard Response format and content for integration into a global content management system. - Respond to Medical Information Requests (via calls/web/emails/letters) and conduct appropriate scientific information exchanges with the requestors. - Participate in scientific training as appropriate to support assigned brands. - Comply with all guidelines, policies, legal, regulatory, and compliance requirements. - Meet or exceed service levels and targets for internal and external customers. - Participate in training & mentoring of new hires or staff changing support areas. - The Senior Scientific Communications Specialist may also be responsible for the following: - Serve as a team lead for 1 or more Clients, therapeutic areas, workstreams, or brands. - Coordinate with Client to schedule meetings and training sessions, and ensure that all team members meet all training requirements. - Manage and distribute overall workload for a brand or therapeutic area. - Coordinate, lead, and participate in workstreams, special projects, pilots, or other activities requested by the client. - Serve as key contact for communications between the Client and Med Communications team. - Maintain active role in Quality Assurance processes, including monitoring of performance indicators. - Provide medical information support via multiple venues including virtual presentations and medical meeting booth coverage. Qualifications - Above average attention to detail, teamwork and initiative. - Ability to interact with other departments within the company and be proficient in written and verbal communication. - Proficient in Microsoft Excel, Power Point and Word, and quickly able to learn new software. - Demonstrated proficiency in drug information communication and management. - Ability to apply regulatory and compliance guidelines to content development. Requirements - Attendance - Always on time for work, including meetings and conferences. Has a strong attendance record and is punctual with deliverables required. - Innovation and Creativity - Has the ability to think in new ways and perspectives and create new ideas. Practical implementation and development of ideas or methods that result in improvements, solutions, or new processes. - Leadership - Has the ability to "lead", influence or guide other individuals, teams, or organizations. Can set goals and motivate others to work towards achieving a common goal. Supports others around them. Communicates and delegates effectively. - Communication Skills - Practices active listening, has quick response times, is clear, concise, and friendly, has the ability to convey thoughts and ideas effectively and efficiently to others, takes and gives constructive feedback, participates in meetings, and connects with others. - Collaboration and Teamwork - Works with others to complete goals, brainstorms ideas, participates in group discussions, and helps analyze problems and finds solutions. Will problem solve with others and take responsibility for their own tasks in a project. - Customer Service - Professional, patient, knowledgeable, adaptable, quickly responds, provides assistance and advice, proactive, resolves issues with care, and provides immediate support. - Time Management - Uses time effectively and productively, prioritizes tasks, delivers results on time. - Work Ethic - Highly motivated, produces consistent high-quality work, has a desire to work hard, takes responsibility, learns from mistakes, follows through with commitments, is professional, is inclusive and welcoming, has respect for others, and goes above and beyond what is required. - Behavior and Attitude - Treats others with respect, projects and promotes a positive attitude, uses appropriate behavior, establishes good working relationships, resolves conflict effectively, and speaks kindly to others. - Self-Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative. - Organized - Possesses the trait of being well organized or following a systematic method of performing a task. - Accuracy - Ability to perform work accurately and thoroughly. - Technical Aptitude - Ability to comprehend complex technical topics and specialized information. - Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience. Skills and Abilities - Education: Advanced degree in pharmacy (PharmD preferred), advanced health care degree, or relevant, equivalent clinical experience. - Experience: Two to four years of related experience in scientific content creation within the pharmaceutical industry, medical education, and/or academia. Demonstrated expertise in drug information communication and management preferred. Drug Information or Clinical Residency preferred. - Computer Skills: Prefer proficiency with Embase, Ovid, and content management systems. - Other Requirements: Prefer pharmaceutical industry writing experience including an understanding of FDA, legal, regulatory and compliance requirements with regards to medical affairs. Work Environment Remote - Med Communications International Lisbon, Portugal

Role Description The Pharmacovigilance Project Manager / Project Lead is a senior client-facing professional responsible for the end-to-end operational management of one or more assigned pharmacovigilance client accounts at Med Communications. The role serves as the primary interface between the client and the MC PV team, ensuring the timely, high-quality, and fully compliant delivery of all contracted pharmacovigilance services across case management, periodic reporting, signal detection, risk management, and related regulatory activities. Operating at a senior level within the PV department, the PV Project Manager / Project Lead combines strong scientific and regulatory knowledge with exceptional project management, communication, and stakeholder management capabilities. The role does not carry direct line management responsibility but exercises functional oversight of PV Specialists and Sr. PV Specialists assigned to the project, coordinating their workload, guiding their day-to-day activities, and supporting their professional development within the context of the client engagement. The role reports directly to the Global Head of Pharmacovigilance and Drug Safety. Qualifications - Excellent working knowledge of relevant PV terminology, ICH guidelines (E2A–E2F, E2C(R2)), GCP, GVP Modules, and applicable regulatory requirements across EU, US, and UK jurisdictions. - Advanced degree in life sciences (PharmD or MD preferred), or a relevant equivalent combination of education and pharmacovigilance experience. - Minimum of five years of pharmacovigilance experience, including at least two years in a project management, project lead, or client-facing account management role at a PV vendor, CRO, or pharmaceutical company. - Demonstrated ability to manage complex, multi-product client accounts across multiple PV domains (case management, periodic reporting, signal detection, risk management). - Experience with drugs, biologics, vaccines, and/or devices is preferred. Requirements - Proficiency with safety databases (Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube Safety), Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), and project management or tracking tools required. - Familiarity with literature search platforms (Embase, OvidPV, PubMed) and document management systems is an advantage. - Working knowledge of global legal, regulatory, and compliance requirements applicable to pharmacovigilance across multiple jurisdictions (EU, US, UK, ICH). - Experience supporting or managing regulatory agency interactions and audit/inspection preparation is preferred. Benefits - Competitive salary and performance-based bonuses. - Comprehensive health, dental, and vision insurance. - Retirement savings plan with company match. - Flexible work arrangements. - Professional development opportunities.

Role Description Are you a Pharmacist looking to take the next step in your career? Do you dream of a role that not only allows you to continue your passion for healthcare but also offers a refreshing change of pace and work environment? If so, consider the exciting opportunity of becoming a Medical Information Specialist in Medical Information and Medical Affairs with Med Communications International. In this outline, we'll explore the benefits of making this transition, from both a scientific and quality of life perspective. Scientific Advancement: - Dive Deeper into Medicine: As a Medical Information Specialist, you'll have the chance to delve deeper into the world of pharmaceuticals and healthcare. You'll be on the front lines of acquiring, organizing, and disseminating critical medical information. - Stay Updated: Pharmaceuticals and medical treatments are constantly evolving. By joining Med Communications, you'll stay at the forefront of the latest advancements. - Transferable Skills: Your experience as a Community Pharmacist equips you with valuable skills like patient communication, drug knowledge, and attention to detail. Quality of Life Improvements: - Work-Life Balance: Say goodbye to long hours standing behind the pharmacy counter. With our remote work option, you can achieve a healthier work-life balance. - Location Flexibility: Embrace the freedom of working from home. Forget about commuting hassles. - Reduced Stress: The fast-paced nature of community pharmacies can be stressful. As a Medical Information Specialist, you'll experience a more calm and structured work atmosphere. - Career Growth: At Med Communications, we value professional development. You'll have opportunities for growth and advancement in a supportive and nurturing environment. - Competitive Compensation: We offer competitive compensation packages, ensuring your hard work is well rewarded. In conclusion, transitioning from a Community Pharmacist to a Medical Information Specialist at Med Communications opens up a world of career possibilities. Qualifications - Degree: MPharm - PharmD or Pharmaceutical Sciences - Experience: At least 3 to 5 years as a Pharmacist - Fluent: C1 or C2 - English Speaker Requirements - Follow the application form instructions - HR team will review your application with feedback - If successful, HR will arrange your Introductory call - A potential online language assessment - 1st formal interview - 2nd formal interview - Offer Benefits - Remote work option for better work-life balance - Location flexibility - Reduced stress in a calm work atmosphere - Opportunities for growth and advancement - Competitive compensation packages

Role Description The Pharmacovigilance Physician is a medical physician (MD, DO, or equivalent) responsible for: - Medical review of individual case safety reports (ICSR) to determine benefit-risk analysis. - Providing medical assessment statements. - Reviewing and analyzing aggregate data sets for benefit-risk assessments. - Reviewing and interpreting clinical and post-marketing data for signal detection, evaluation, and verification. - Participating in safety meetings with clients. - Assisting in drafting, reviewing, and refining medical-content intensive portions of periodic safety reports (PADERs, PSURs, DSURs, PBRERs, IND Annual Reports). - Updating Investigators Brochure (IB) and Clinical Safety Summaries (ISS). - Handling US and international product labeling documents and ad hoc safety information requests from regulatory authorities. - Drafting, reviewing, and refining risk management plans and risk evaluation and mitigation strategies. - Supporting the Qualified Person for Pharmacovigilance as required. Qualifications - Licensed medical physician in good-standing in the state(s) of licensure (MD, DO, etc.) plus one (1) year pharmacovigilance experience or other equivalent experience. - Or unlicensed medical physician (MD, DO, etc.) with no record of past or present Medical Board disciplinary action; plus ten (10) years of combined pharmacovigilance experience, clinical healthcare provider experience, or other equivalent experience. Requirements - Self-Motivated - Ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative. - Organized - Possessing the trait of being organized or following a systematic method of performing a task. - Prefer board certification in related area for client being supported. - Epidemiology degree is a plus. - One year related pharmacovigilance experience in the pharmaceutical industry or other equivalent experience, such as clinical trial investigator, health authority inspector, epidemiologist, etc. - Prefer proficiency with Microsoft Office and content management systems. - Understanding of legal, regulatory and compliance requirements with regards to pharmacovigilance based on global regulations for EU, FDA, Japan MHLW, UK MHRA, and other entities, and ICH guidelines. Company Description

Pharmacovigilance Manager – Benefit Risk  Position Summary The Pharmacovigilance (PV) Manager – Benefit Risk is a senior safety professional responsible for leading and overseeing benefit-risk evaluation activities across assigned products and client portfolios. This role ensures the continuous assessment of product safety profiles through structured signal evaluation, safety data analysis, and integrated benefit-risk assessments in compliance with global regulatory requirements, including ICH E2E, ICH E2C(R2), EMA GVP Modules V and IX, and FDA guidance.  The PV Manager – Benefit Risk acts as a subject matter expert in benefit-risk methodology, collaborating cross-functionally with signal management, aggregate reporting, medical review, clinical, and regulatory teams to support proactive safety surveillance and informed decision-making throughout the product lifecycle.  Essential Functions - Lead and oversee benefit-risk assessments for assigned products, ensuring a proactive and continuous evaluation of safety and efficacy data. - Author and review benefit-risk sections for aggregate reports (PSURs/PBRERs, DSURs, PADERs), risk management plans (RMPs), and other regulatory documents. - Collaborate closely with Signal Management teams to evaluate and contextualize safety signals within the overall benefit-risk profile. - Perform structured benefit-risk evaluations using qualitative and quantitative methodologies (e.g., BRAT framework, weighted analyses, or similar approaches). - Integrate data from multiple sources, including clinical trials, post-marketing surveillance, literature, and real-world evidence, into comprehensive benefit-risk evaluations. - Support safety governance activities, including preparation of Safety Management Team (SMT) or Safety Review Committee (SRC) materials. - Provide strategic input into risk minimization measures and risk management strategies, including RMP development and updates. - Ensure alignment of benefit-risk conclusions across regulatory documents and submissions. - Review safety data outputs (line listings, summary tabulations, signal reports) to support benefit-risk decision-making. - Act as a key point of contact for clients and internal stakeholders on benefit-risk topics and safety strategy. - Lead, supervise, and mentor PV Specialists and Senior PV staff contributing to benefit-risk and signal evaluation activities. - Contribute to the development and continuous improvement of SOPs, work instructions, and templates related to benefit-risk evaluation. - Maintain current knowledge of global pharmacovigilance regulations, methodologies, and evolving best practices in benefit-risk assessment. - Support audits and inspections, ensuring readiness and appropriate documentation of benefit-risk decisions and processes. - Ensure compliance with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Education Advanced degree in life sciences, pharmacy (PharmD), or medicine (MD) preferred. Additional qualifications in pharmacoepidemiology, biostatistics, or regulatory affairs are an advantage. Experience Minimum 5 years of pharmacovigilance experience, with at least 2–3 years focused on signal management and/or benefit-risk evaluation. Demonstrated experience in authoring or contributing to benefit-risk sections of aggregate reports (PSUR/PBRER required). Experience with RMP development and signal evaluation processes strongly preferred. Experience working within a CRO, PV vendor, or pharmaceutical company in a global environment.  Computer Skills  Safety databases (e.g., Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Safety, AB Cube SafetyEasy). Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Literature databases (e.g., Embase, PubMed). Familiarity with signal detection tools (e.g., Empirica, PV Analytics tools) and data visualization platforms is an advantage.  Competency Statements  Analytical Thinking – Ability to interpret complex datasets and translate them into meaningful benefit-risk insights. Critical Thinking - Ability to evaluate multiple sources of information and make sound, evidence-based decisions. Attention to Detail – Ensures accuracy and consistency across safety evaluations and documentation. Leadership – Ability to guide, mentor, and support team members in benefit-risk activities. Communication, Written – Ability to clearly articulate complex benefit-risk concepts in regulatory documents. Communication, Oral – Ability to effectively present safety assessments to stakeholders and clients. Problem Solving – Ability to proactively identify and resolve safety-related issues. Collaboration – Ability to work effectively across cross-functional teams. Customer Oriented – Ability to understand and meet client needs while maintaining compliance. Technical Aptitude – Strong understanding of pharmacovigilance regulations and benefit-risk methodologies. Accountability – Takes ownership of deliverables and ensures timely completion. Adaptability – Ability to adjust to evolving regulatory requirements and client expectations.  Work Environment  Remote: Romania / Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. To apply for this role: Step 1: Proceed to follow the form instructions Step 2: Our HR team will review your application with feedback Step 3: If successful, HR will arrange your Introductory call Step 4: A potential online language assessment Step 5: 1st formal interview Step 6: 2nd formal interview Step 7: Offer NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.

Pharmacovigilance Manager – Benefit Risk  Position Summary The Pharmacovigilance (PV) Manager – Benefit Risk is a senior safety professional responsible for leading and overseeing benefit-risk evaluation activities across assigned products and client portfolios. This role ensures the continuous assessment of product safety profiles through structured signal evaluation, safety data analysis, and integrated benefit-risk assessments in compliance with global regulatory requirements, including ICH E2E, ICH E2C(R2), EMA GVP Modules V and IX, and FDA guidance.  The PV Manager – Benefit Risk acts as a subject matter expert in benefit-risk methodology, collaborating cross-functionally with signal management, aggregate reporting, medical review, clinical, and regulatory teams to support proactive safety surveillance and informed decision-making throughout the product lifecycle.  Essential Functions - Lead and oversee benefit-risk assessments for assigned products, ensuring a proactive and continuous evaluation of safety and efficacy data. - Author and review benefit-risk sections for aggregate reports (PSURs/PBRERs, DSURs, PADERs), risk management plans (RMPs), and other regulatory documents. - Collaborate closely with Signal Management teams to evaluate and contextualize safety signals within the overall benefit-risk profile. - Perform structured benefit-risk evaluations using qualitative and quantitative methodologies (e.g., BRAT framework, weighted analyses, or similar approaches). - Integrate data from multiple sources, including clinical trials, post-marketing surveillance, literature, and real-world evidence, into comprehensive benefit-risk evaluations. - Support safety governance activities, including preparation of Safety Management Team (SMT) or Safety Review Committee (SRC) materials. - Provide strategic input into risk minimization measures and risk management strategies, including RMP development and updates. - Ensure alignment of benefit-risk conclusions across regulatory documents and submissions. - Review safety data outputs (line listings, summary tabulations, signal reports) to support benefit-risk decision-making. - Act as a key point of contact for clients and internal stakeholders on benefit-risk topics and safety strategy. - Lead, supervise, and mentor PV Specialists and Senior PV staff contributing to benefit-risk and signal evaluation activities. - Contribute to the development and continuous improvement of SOPs, work instructions, and templates related to benefit-risk evaluation. - Maintain current knowledge of global pharmacovigilance regulations, methodologies, and evolving best practices in benefit-risk assessment. - Support audits and inspections, ensuring readiness and appropriate documentation of benefit-risk decisions and processes. - Ensure compliance with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Education Advanced degree in life sciences, pharmacy (PharmD), or medicine (MD) preferred. Additional qualifications in pharmacoepidemiology, biostatistics, or regulatory affairs are an advantage. Experience Minimum 5 years of pharmacovigilance experience, with at least 2–3 years focused on signal management and/or benefit-risk evaluation. Demonstrated experience in authoring or contributing to benefit-risk sections of aggregate reports (PSUR/PBRER required). Experience with RMP development and signal evaluation processes strongly preferred. Experience working within a CRO, PV vendor, or pharmaceutical company in a global environment.  Computer Skills  Safety databases (e.g., Oracle Argus Safety, ArisGlobal LifeSphere, Veeva Safety, AB Cube SafetyEasy). Microsoft Office Suite (Word, Excel, PowerPoint, Outlook). Literature databases (e.g., Embase, PubMed). Familiarity with signal detection tools (e.g., Empirica, PV Analytics tools) and data visualization platforms is an advantage.  Competency Statements  Analytical Thinking – Ability to interpret complex datasets and translate them into meaningful benefit-risk insights. Critical Thinking - Ability to evaluate multiple sources of information and make sound, evidence-based decisions. Attention to Detail – Ensures accuracy and consistency across safety evaluations and documentation. Leadership – Ability to guide, mentor, and support team members in benefit-risk activities. Communication, Written – Ability to clearly articulate complex benefit-risk concepts in regulatory documents. Communication, Oral – Ability to effectively present safety assessments to stakeholders and clients. Problem Solving – Ability to proactively identify and resolve safety-related issues. Collaboration – Ability to work effectively across cross-functional teams. Customer Oriented – Ability to understand and meet client needs while maintaining compliance. Technical Aptitude – Strong understanding of pharmacovigilance regulations and benefit-risk methodologies. Accountability – Takes ownership of deliverables and ensures timely completion. Adaptability – Ability to adjust to evolving regulatory requirements and client expectations.  Work Environment  Remote: Romania / Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. To apply for this role: Step 1: Proceed to follow the form instructions Step 2: Our HR team will review your application with feedback Step 3: If successful, HR will arrange your Introductory call Step 4: A potential online language assessment Step 5: 1st formal interview Step 6: 2nd formal interview Step 7: Offer NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.

Pharmacovigilance Lead Aggregate Reporting Position Summary The PV Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned client portfolios. The role encompasses the full lifecycle of periodic and aggregate reporting — including PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP Module VII, ICH E2C(R2), ICH E2F, and FDA requirements. The role acts as the subject matter expert for aggregate reporting and collaborates with signal management, case processing, medical review, and client teams to deliver submission-ready documents within regulatory deadlines. Essential Functions - Lead and supervise the planning, writing, compilation, quality review and submission of PSURs/PBRERs, DSURs, PADERs, ADCOs, Line Listings for assigned client products. - Develop and maintain aggregate reporting timelines and submission schedules, ensuring alignment with IBDs, data lock points and regulatory submission deadlines. Coordinate data collection from all relevant teams to ensure report completeness and accuracy. - Integrate signal evaluation outcomes and benefit-risk assessments into periodic safety reports in collaboration with the Signal Management Lead and medical reviewers. - Review and quality-check safety database outputs (line listings, summary tabulations, etc) for inclusion in aggregate reports. - Author or oversee authoring of case narratives, cumulative analyses, and benefit-risk evaluation sections. - Manage the review and approval workflow for aggregate reports, coordinating input from medical reviewers, the QPPV and client stakeholders, as appropriate. - Contribute to Risk Management Plans (RMPs) and REMS safety sections as required. - Lead, supervise and mentor PV Specialists and Sr. PV Specialists assigned to perform aggregate reporting support activities. - Develop and review SOPs, Work Instructions and report templates related to aggregate reporting in collaboration with the PV Quality Manager. - Maintain up-to-date knowledge of global aggregate reporting requirements and proactively communicate regulatory changes to the PV team and clients. - Ensure inspection and audit readiness and actively support QA activities including CAPA follow-up. - Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Education: Advanced degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred. A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an advantage. Experience: Minimum 4 years of PV experience, with at least 2 years focused on aggregate/periodic safety report writing at a PV vendor, CRO, or pharmaceutical company. End-to-end PSUR/PBRER experience required; DSURs, PADERs, and RMPs strongly preferred. Computer Skills: Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), document management systems, Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), literature databases (Embase, PubMed). Familiarity with electronic submission tools and aggregate reporting softwares is an advantage. Competency Statements - Self-Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative. - Above average attention to detail, teamwork, and initiative. - Organized - Possesses the trait of being well organized or following a systematic method of performing a task. - Accuracy - Ability to perform work accurately and thoroughly. - Technical Aptitude - Ability to comprehend complex technical topics and specialized information. - Tactful - Ability to show consideration for and maintain good relations with others. - Responsible - Ability to be held accountable or answerable for ones conduct. - Problem Solving - Ability to find a solution for or to deal proactively with work-related problems. - Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others. - Customer Oriented - Ability to take care of the clients needs while following company procedures. - Communication, Written - Ability to communicate in writing clearly and concisely. - Communication, Oral - Ability to communicate effectively with others using the spoken word. - Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience. Work Environment Remote: Romania / Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.

Pharmacovigilance Signal Detection Lead Summary The Pharmacovigilance Signal Detection Lead is a senior expert responsible for leading and executing signal detection and evaluation activities across assigned client portfolios. The role combines scientific and epidemiological expertise with operational oversight of signal management workflows, ensuring that emerging safety signals are identified, assessed, prioritized, and communicated in compliance with applicable regulatory requirements (EMA GVP Module IX, ICH E2E, FDA) and client-specific procedures. The Signal Management Lead serves as the subject matter expert for signal-related activities and collaborates closely with medical reviewers, project leads, and client stakeholders. Essential Functions - Lead the design, execution, and oversight of signal detection activities, including quantitative analyses (PRR, ROR, EBGM) applied to spontaneous reporting databases (FAERS, EudraVigilance, VigiBase). - Conduct qualitative signal evaluation integrating data from spontaneous reports, clinical trials, post-authorization safety studies, scientific literature, social media monitoring, as applicable - Prepare and review signal detection reports, signal evaluation reports, and signal management plans per client SOPs and regulatory expectations. - Ensure signal management activities are completed and reported within regulatory timelines to the appropriate entities (EMA, FDA, UK MHRA). - Oversees systematic medical literature searches (Embase, PubMed) and supervise triage and assessment of results for signal-relevant publications and ICSRs. - Collaborate with the aggregate reporting team on signal-related sections of PSURs/PBRERs and DSURs. - Contribute to Risk Management Plans (RMPs) and REMS as required. - Lead, supervise, and mentor PV Specialists and Sr. PV Specialists assigned to signal detection activities - Develop and review SOPs and Work Instructions related to signal management in collaboration with the PV Quality Manager and the PV Medical Writing Manager - Ensure inspection and audit readiness and actively support QA activities including CAPA follow-up. - Interact with the PV Physician and QPPV for scientific exchange pertaining to signal assessment and benefit-risk implications. - Comply with all applicable guidelines, policies, legal, regulatory, and compliance requirements. Education: Advanced degree in pharmacy (PharmD preferred), medicine, life sciences, or epidemiology. A postgraduate qualification in pharmacoepidemiology or drug safety is an advantage. Experience: Minimum 4 years of PV experience, with at least 2 years focused on signal detection or pharmacoepidemiology at a PV vendor, CRO, or pharmaceutical company. Hands-on experience with signal detection methods and regulatory safety databases (FAERS, EudraVigilance, VigiBase) required. Computer Skills: Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), signal detection tools, literature databases (Embase,PubMed), Microsoft Office Suite. Familiarity with statistical tools is an advantage. WORK ENVIRONMENT Remote: Romania / Poland or Portugal The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate. To apply for this role: Step 1: Proceed to follow the form instructions Step 2: Our HR team will review your application with feedback Step 3: If successful, HR will arrange your Introductory call Step 4: A potential online language assessment Step 5: 1st formal interview Step 6: 2nd formal interview Step 7: Offer NB* To be fully informed, the Job Description will be provided at Step 3 along with further information so that all aspects of the role are covered as much as possible. Disclaimer By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status. Recruitment Agency Notice: Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes. Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy. Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.