Manager, Pharmacovigilance and Medical Information

Manager, Pharmacovigilance & Medical Information – France About This Role: As Manager, Pharmacovigilance & Medical Information, you will play a key role in ensuring patient safety and regulatory compliance across Biogen’s pharmacovigilance activities. This position has a unique dual scope, with approximately 50% of the role focused on global pharmacovigilance activities for Biogen’s biosimilar portfolio in partnership with Samsung Bioepis, and 50% focused on local Pharmacovigilance and Medical Information activities for Biogen France. You will act as a key pharmacovigilance partner and subject matter expert, collaborating closely with local and global Biogen teams, Samsung Bioepis, health authorities, healthcare professionals, patients and external vendors. You will also contribute to continuous improvement, inspection and audit readiness, and the development of robust PV processes. What You’ll Do: Provide oversight and governance of global pharmacovigilance activities for Samsung Bioepis biosimilars in accordance with applicable Pharmacovigilance Agreements (PVAs). Act as a key Biogen PV contact for Samsung Bioepis and collaborate closely with the Biogen France PV Responsible Person, Biogen EU QPPV and Samsung Bioepis EU QPPV. Develop, improve and implement regional and local pharmacovigilance processes, including management and coordination of PV agreements and controlled documentation. Oversee PV activities related to Organized Data Collection Programs (ODCPs) for biosimilars and monitor relevant Pharmacovigilance and Medical Information metrics. Contribute to global and local PV inspection and audit readiness in collaboration with Quality, Compliance and partner teams. Monitor the benefit-risk profile of Biogen products marketed or used through Derogatory Access Programs in France. Collect, assess, follow up, document and ensure appropriate processing and quality control of pharmacovigilance cases in accordance with applicable procedures and regulations. Support local signal detection, non-compliant use monitoring and the management of requests and reports for French Health Authorities. Oversee local PV vendors and contribute to PV requirements within commercial and non-commercial agreements. Review local organized data collection programs and other local programs from a pharmacovigilance perspective. Develop and deliver pharmacovigilance training for Biogen France employees and relevant external partners. Act as Deputy Pharmacovigilance Responsible Person (RPV) in the absence of the RPV and serve as a local safety expert. Supervise and support junior associates and trainees. Manage Medical Information requests from healthcare professionals and patients regarding Biogen products and oversee Medical Information vendors. Contribute to the development and validation of standard Medical Information response documents. Support the PV and Medical Information Quality Management System, including procedures, work instructions, deviations/non-conformities, reconciliations, quality controls and KPI monitoring. Partner cross-functionally with local, regional and global stakeholders to continuously improve Pharmacovigilance and Medical Information processes.

You are an experienced Pharmacovigilance professional with strong scientific judgment and a thorough understanding of the French and European regulatory environment. You are comfortable balancing operational responsibilities with oversight, governance and cross-functional collaboration. You communicate clearly with a broad range of stakeholders and are able to evaluate complex scientific information, identify potential safety risks and translate regulatory requirements into effective operational processes. You are rigorous and detail-oriented while remaining proactive, pragmatic and adaptable in a dynamic international environment.

Strong knowledge of French and EU pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP).