Manager, Pharmacovigilance and Medical Information
Biogen · Paris, France
SafetyFull-timeCompany career page
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Role summary
Manager overseeing pharmacovigilance and medical information for Biogen France and Samsung Bioepis biosimilar portfolio. Role combines global oversight of safety activities with local regulatory compliance, case management, and stakeholder engagement across French and European markets.
What they're looking for
- Strong knowledge of French and EU pharmacovigilance regulations and Good Pharmacovigilance Practices
- Minimum 4 years professional experience in pharmacovigilance and medical information
- Pharm.D or M.D. degree
- Demonstrated ability to assess safety information and benefit-risk considerations
- Experience with pharmacovigilance case management and safety databases
- Fluent in French with strong scientific English writing capability
- Understanding of PV quality, compliance requirements, audit and inspection readiness
What you'll be doing
- Oversee global pharmacovigilance activities for Samsung Bioepis biosimilars and manage partnership agreements
- Develop and implement regional pharmacovigilance processes, including agreement management and documentation control
- Collect, assess, and ensure appropriate processing of pharmacovigilance cases per applicable procedures
- Monitor benefit-risk profiles, conduct signal detection, and support French health authority requests
- Act as Deputy Pharmacovigilance Responsible Person and supervise junior associates and trainees
Privacy & handoff
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