Manager, Pharmacovigilance and Medical Information
Core
Ensure patient safety and regulatory compliance for Biogen's biosimilar portfolio globally and local PV activities in France.
Role type
Manager, Pharmacovigilance and Medical Information
Builds
Global PV processes for Samsung Bioepis biosimilars and local PV/Medical Information operations for Biogen France
Domain
Biopharmaceuticals / Pharmacovigilance / Medical Information
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
French and EU pharmacovigilance regulations (GVP), PV case management, safety database usage, benefit-risk assessment, audit/inspection readiness, vendor management, Medical Information response validation, signal detection, training delivery
Preferred skills
None stated
Technologies
None stated
Responsibilities
Oversee global PV activities for Samsung Bioepis biosimilars; Act as key PV contact for Samsung Bioepis; Develop and implement regional/local PV processes; Monitor ODCPs and PV metrics; Contribute to inspection and audit readiness; Monitor benefit-risk profile for Derogatory Access Programs; Manage PV cases and quality control; Support local signal detection and health authority reporting; Oversee local PV vendors; Review local data collection programs; Deliver PV training; Act as Deputy Pharmacovigilance Responsible Person; Supervise junior associates; Manage Medical Information requests and vendors; Support PV/Medical Information Quality Management System; Partner cross-functionally to improve processes
Seniority
Manager, hands-on IC with team supervision
