Manager, Pharmacovigilance and Medical Information

About the role

Biogen is looking for a Manager, Pharmacovigilance and Medical Information in France. The role is split roughly 50/50: half focuses on global pharmacovigilance for Biogen's biosimilar portfolio in partnership with Samsung Bioepis, and half on local pharmacovigilance and medical information for Biogen France. It is a management position based in France with a hybrid working model.

Key responsibilities

• Provide oversight and governance of global pharmacovigilance activities for Samsung Bioepis biosimilars under the applicable Pharmacovigilance Agreements, and act as the key Biogen PV contact for Samsung Bioepis.
• Develop, improve and implement regional and local PV processes, including PV agreements and controlled documentation, and oversee ODCP-related PV activities and PV/Medical Information metrics.
• Contribute to PV inspection and audit readiness with Quality, Compliance and partner teams, and monitor the benefit-risk profile of products marketed or used through Derogatory Access Programs in France.
• Collect, assess, follow up and document PV cases, support local signal detection and non-compliant use monitoring, and manage requests and reports for French Health Authorities.
• Oversee local PV vendors, review local organized data collection programs, and supervise and train junior associates and trainees.
• Manage Medical Information requests from healthcare professionals and patients, oversee Medical Information vendors, develop standard response documents and support the PV and Medical Information Quality Management System.
• Deliver PV training, act as Deputy Pharmacovigilance Responsible Person in the RPV's absence, and partner cross-functionally to improve PV and Medical Information processes.

Required profile

• Pharm.D or M.D, with a minimum of 4 years of professional experience in pharmacovigilance and medical information.
• Fluent French and strong written scientific English, able to read and prepare scientific documents, reports and communications.
• Experience with pharmacovigilance case management, documentation and safety databases, and audit and inspection readiness.
• Ability to balance operational responsibilities with oversight, governance and cross-functional collaboration.

Required skills

• Strong knowledge of French and EU pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).
• Assessment of safety information, benefit-risk considerations and potential product quality concerns.
• Excellent organizational skills, attention to detail and stakeholder management in multidisciplinary teams.