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.

Role Description V2X is currently seeking a candidate for a part-time contributor for the PW ETU F135 Program ‘Great Engine War’ case study. The contributor will assist in the effort to research, coordinate with appropriate stakeholders, write and publish an end-to-end F135 Program Case Study that captures program lessons learned and captures critical program knowledge. - Research, coordinate with appropriate stakeholders, write and publish end-to-end F135 Program Case Study. Qualifications - Extensive knowledge of the ETU F135 Program. - Excellent communication skills, both oral and written. - Working knowledge of MS Word, Excel, and Project. Requirements - Proficient in Microsoft Office products; significant use of Microsoft Excel and PowerPoint. - Credentials and computer asset to be provided by customer. Benefits - V2X is committed to building a diverse and inclusive environment. - Fostering a culture that promotes core values: Professionalism, Integrity, and Respect. - Equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, or status as a protected veteran.

RateHawk is part of Emerging Travel Group — a pioneering travel-tech company also known for its two other brands, ZenHotels and Roundtrip, spanning over 220 markets worldwide. Our mission is to create, distribute, and operate the most convenient travel products. We constantly innovate and break the rules of the highly complex travel industry to make travel more widely available for individuals, more rewarding for professionals, and simpler for everyone. As an API Optimization Manager, you will play a pivotal role in ensuring the seamless integration and optimal performance of our API solutions for our partners. The ideal candidate will possess strong analytical skills, technical expertise, and the ability to foster strong relationships with both internal teams and external clients. This is a remote vacancy open to candidates residing in Europe. What You’ll Do: - Continuous Monitoring and Improvement: - Continuously monitor commercial and technical metrics for our partners to ensure constant improvements; - Track and analyze key performance indicators (KPIs) such as Bans, Search & Booking Timeouts, Mapping Assessment, and Error Rates; - Detailed Analysis and Insights: - Conduct detailed analysis of metrics to identify areas requiring improvement; - Formulate conclusive insights and actionable recommendations to enhance performance and efficiency; - Internal Reporting and Coordination: - Report identified issues to relevant internal teams (Product, API Support, Pricing, etc.) to ensure timely resolution; - Maintain clear and effective communication channels to facilitate prompt issue resolution; - Feature Development and Scaling: - Foster the development of new features in the market; - Scale new features for quick implementation by clients, ensuring they derive maximum benefit from our solutions; - Collaboration with Commercial Teams: - Work closely with the commercial teams to ensure client KPIs are met; - Provide strategic recommendations to improve the performance of top clients; - Technical Gap Analysis and Resolution: - Identify technical gaps in a client's integration; - Collaborate with clients to resolve integration issues and enhance their API usage experience; - Spend approximately 40% of your working time on business trips, including meetings with clients, industry events, and other business-related events.