Biomapas

• Responsible for processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review and reporting to client (s) or agencies for assigned projects) • Perform reconciliation of safety data • Participate in Project / Study Team meetings as the Safety and Pharmacovigilance representative • Oversee the planning, coordination, and quality review of aggregate safety reports, support the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL). • Supervision of local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans and risk minimization activities • Collaborate with medical, safety physicians, and data management, IT, other functions to ensure timely and accurate reporting or reports delivery • Act as Biomapas and/or contractual partners 24/7 local contact person or back up for pharmacovigilance at local level • Ensure the survey and monitoring of national / regional pharmacovigilance regulations • Collection and processing of any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source • Support of weekly monitoring of local or global literature review • Support of continuous safety profile monitoring, detection of new signals and evaluation • Participate in related inspection and/or audits, including post inspection/audit support, when required

Role Description Join our global Pharmacovigilance team as a Medical/Clinical Safety Specialist. The Medical/Clinical Safety Specialist is responsible for assuring compliance with the Quality Management System. This role involves: - Participating in the collection, safety review, processing, and reporting of safety information in compliance with applicable global and local regulations and Biomapas standard operating procedures and guidelines. - Interacting and exchanging relevant safety and pharmacovigilance information with local Competent Authorities, Biomapas, and Biomapas contractual partners. - Position is in any EU country. All CV's must be submitted in English language. Responsibilities include: - Processing of ICSRs, Serious Adverse Event (SAE) from Clinical trials (safety database entry, tracking, narrative writing, requesting follow-up from site, quality checks/review, and reporting to clients or agencies for assigned projects). - Performing reconciliation of safety data. - Participating in Project / Study Team meetings as the Safety and Pharmacovigilance representative. - Overseeing the planning, coordination, and quality review of aggregate safety reports, supporting the preparation and submission of regulatory safety documents (e.g., DSURs, 6MLL). - Supervising local handling, including preparation and submission, of Periodic Safety Update Reports, Risk Management Plans, and risk minimization activities. - Collaborating with medical, safety physicians, and data management, IT, and other functions to ensure timely and accurate reporting or reports delivery. - Acting as Biomapas and/or contractual partners 24/7 local contact person or backup for pharmacovigilance at the local level. - Ensuring the survey and monitoring of national/regional pharmacovigilance regulations. - Collecting and processing any medical enquiry/inquiry/answer received via phone/e-mail/fax or by other means from any source. - Supporting weekly monitoring of local or global literature review. - Supporting continuous safety profile monitoring, detection of new signals, and evaluation. - Participating in related inspections and/or audits, including post-inspection/audit support, when required. Qualifications - University degree in the Life Science field. - At least 5+-year’s experience in Pharmacovigilance, clinical safety, and clinical development with expert knowledge of pharmacovigilance legislation. - Knowledge of international regulations (ICH, EU GVP Modules, FDA). - Experience working with PV databases (e.g., Veeva Vault Safety, Argus, ArisG, etc.) and MedDRA coding. - Strong computer literacy. - Ability to interpret and apply global drug safety regulations. - Fluent English language. - Eager to adopt automations and new technologies in daily tasks. - Attention to detail, time-management, and problem-solving skills. - CRO experience is a plus. - Project management experience is a plus. Benefits - Professional growth and career opportunities. - International team and environment. - Bonus based on annual performance. - Personal accident and business trip insurance. - Additional health insurance. - Remote/home based. - Rewarding referral policy. - Workplace establishment allowance (fully remote). - Team building, global meetings, B active events.

• Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulation • Collect, process and communicate of safety information • Medical Information Requests handling • Maintain and establish of quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review in Lithuania, Malta, UK and IE • Participate in inspection and/or audits • Act as a Local Safety Officer for Lithuania and Malta • Ensure the survey and monitoring of national pharmacovigilance regulations

• Ensure weekly monitoring of local and global literature review • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulations • Collect, process, and communicate of safety information, product quality complaints and medical device incidents • Maintain and establish quality standards for local pharmacovigilance activities • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

• Act as a Local Safety Officer and Medical Information Specialist in Italy (nomination as per local requirements) • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulations • Collect, process, and communicate of safety information, product quality complaints and medical device incidents • Maintain and establish quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

• Act as a Local Safety Officer and Medical Information Specialist in Spain (nomination as per local requirements) • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulations • Collect, process, and communicate of safety information, product quality complaints and medical device incidents • Maintain and establish quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

• Act as a National Contact Person in UK and North Ireland • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulation • Collect, process and communicate of safety information • Maintain and establish of quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

• Act as a Local Safety Officer and Medical Information Specialist in Romania (nomination as per local requirements) • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulations • Collect, process, and communicate of safety information, product quality complaints and medical device incidents • Maintain and establish quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

• Perform local operations and ensure compliance with safety regulations and procedures • Manage and share safety information with relevant authorities and clients • Serve as the main contact for safety matters with authorities and clients • Ensure timely handling of safety information for products • Review local literature • Medical Information Requests handling

• Join our Pharmacovigilance team as Associate Director International PV. • Responsible for the leadership and oversight of the international PV office. • Ensure compliance with international regulations, guidelines, and internal quality standards. • Oversee and manage a team of EU/UK QPPVs and PV personnel. • Support operational, financial, and client objectives of the sub-department. • Drive process excellence and effective management of PV operational activities. • Influence the performance of the quality system and PV activities. • Oversee sub department forecasting and contribute to budget planning. • Manage PV projects and customer activities, supervising core PV deliverables. • Ensure oversight of the contractual partner safety data exchange agreements. • Oversee inspection/audit strategy, readiness, and finding remediation. • Monitor regulatory changes and ensure PV compliance across assigned projects. • Manage assigned team, set goals, evaluate performance, and support decisions on promotions. • Identify areas for improvement and proactively propose solutions.