Global & Local Pharmacovigilance Manager, France

Biogen; Paris; Hybrid; EUR 90,000 - 150,000; Full time

Job summary

Biogen France is seeking a Manager, Pharmacovigilance & Medical Information to oversee global PV activities for biosimilars in collaboration with Samsung Bioepis and manage local PV/MI activities for Biogen France. The role requires leading PV processes, inspections readiness, and cross-functional collaboration across international teams.

You will develop PV processes, manage data collection programs, supervise junior staff, and ensure high standards of safety reporting and regulatory compliance

Qualifications

• Knowledge of French and EU pharmacovigilance regulations (GVP).
• Experience in pharmacovigilance and medical information.
• Ability to assess safety information and benefit-risk considerations.
• Experience with pharmacovigilance case management and safety databases.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide oversight of global PV activities for biosimilars in collaboration with Samsung Bioepis.
• Serve as PV contact for Samsung Bioepis and Biogen France PV teams.
• Develop and implement PV processes locally and regionally.
• Oversee PV activities for organized data collection programs and KPIs.
• Contribute to PV inspection and audit readiness.
• Monitor safety signals and manage reports for health authorities in France.
• Manage local PV vendors and PV requirements in agreements.
• Deliver PV training for Biogen France and external partners.

Skills

GVP knowledge

PV & Medical Information experience

Safety databases

Regulatory understanding

Stakeholder management

English/French proficiency

Education

Pharm.D or M.D.

Tools

PV case management systems

Pharmacovigilance databases

Job description

Biogen France is seeking a Manager, Pharmacovigilance & Medical Information to oversee global PV activities for biosimilars in collaboration with Samsung Bioepis and manage local PV/MI activities for Biogen France. The role requires leading PV processes, inspections readiness, and cross-functional collaboration across international teams.

You will develop PV processes, manage data collection programs, supervise junior staff, and ensure high standards of safety reporting and regulatory compliance