PV & Medical Information Lead, France & Global Biosimilars

Biogen; Paris; Ibrido; EUR 85.000 - 110.000; Tempo pieno

Descrizione del lavoro

Biogen in France is seeking a Manager of Pharmacovigilance & Medical Information to lead global PV activities for Samsung Bioepis biosimilars and to manage local PV and Medical Information for Biogen France. The role collaborates with local and global Biogen teams, Samsung Bioepis, health authorities, and external partners.

The ideal candidate will have Pharm.D or M.D. with 4+ years in PV/MI, strong regulatory knowledge, and proven ability to drive processes, training, and audits in a hybrid,

Competenze

• Strong knowledge of French and EU pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
• Demonstrated experience in pharmacovigilance and medical information.
• Ability to assess safety information, benefit-risk considerations and potential product quality concerns.
• Experience with pharmacovigilance case management, documentation and safety databases.
• Strong communication and stakeholder management skills.

Mansioni

• Provide oversight and governance of global pharmacovigilance activities for Samsung Bioepis biosimilars.
• Act as a key Biogen PV contact for Samsung Bioepis and collaborate with Biogen France PV RP, Biogen EU QPPV and Samsung Bioepis EU QPPV.
• Develop, improve and implement regional and local pharmacovigilance processes and manage PV agreements and documentation.
• Oversee PV activities related to Organized Data Collection Programs (ODCPs) for biosimilars and monitor PV metrics.
• Contribute to PV inspection and audit readiness with Quality, Compliance and partner teams.
• Monitor the benefit-risk profile of Biogen products in Derogatory Access Programs in France.
• Collect, assess, follow up, document PV cases per procedures and regulations.
• Support local signal detection, non-compliant use monitoring and reports to French Health Authorities.
• Oversee local PV vendors and PV requirements within commercial and non-commercial agreements.
• Review local organized data collection programs from a pharmacovigilance perspective.
• Develop and deliver PV training for Biogen France employees and external partners.
• Act as Deputy Pharmacovigilance Responsible Person and supervise junior staff.

Conoscenze

Pharmacovigilance

Medical information

GVP knowledge

Regulatory knowledge

Stakeholder management

French language

Formazione

Pharm.D

MD

Descrizione del lavoro

Biogen in France is seeking a Manager of Pharmacovigilance & Medical Information to lead global PV activities for Samsung Bioepis biosimilars and to manage local PV and Medical Information for Biogen France. The role collaborates with local and global Biogen teams, Samsung Bioepis, health authorities, and external partners.

The ideal candidate will have Pharm.D or M.D. with 4+ years in PV/MI, strong regulatory knowledge, and proven ability to drive processes, training, and audits in a hybrid,