Pharmacovigilance Specialist (Medical/Clinical Safety)

Join our global Pharmacovigilance team as a Pharmacovigilance Specialist (Medical/Clinical Safety).

Pharmacovigilance Specialist (Medical/Clinical Safety) is responsible for assuring compliance with the Quality Management System. 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.

Position is in any EU country.

Responsibilities:

• 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