Manager, Pharmacovigilance and Medical Information

Biogen; Paris; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Biogen in France seeks a Manager, Pharmacovigilance & Medical Information to lead global PV activities for biosimilars with Samsung Bioepis and to oversee Biogen France PV/MI. The role requires strong regulatory knowledge, English/French fluency, and cross-functional collaboration across local and global teams.

Hybrid work in France, with leadership responsibilities, vendor management, and QPPV collaboration. Minimum 4+ years PV/MI experience and a PharmD or MD are required.

Qualifications

• Fluent French and strong written English for scientific documentation.
• Experience in pharmacovigilance and medical information required.
• Ability to assess safety information and regulatory requirements.
• Experience with case management, documentation and safety databases.

Responsabilités

• Provide oversight of global PV activities for biosimilars per PVAs.
• Serve as Biogen PV contact with Samsung Bioepis and EU QPPV collaboration.
• Develop and implement regional/local PV processes and documentation.
• Oversee PV activities for ODCPs and monitor PV metrics.
• Support PV inspections readiness and cross-functional compliance.
• Monitor benefit-risk for Biogen products in France; handle MI requests.
• Manage local PV vendors and PV requirements across agreements.
• Review local data programs from a PV perspective and train Biogen France staff.

Connaissances

PV governance

Global PV

Medical Information

Regulatory compliance

GVP knowledge

PV case management

Safety databases

Cross-functional collaboration

Audits & inspections

Vendor management

Signal detection

Training

Formation

PharmD or MD

4+ years PV/MI

Outils

PV database

Safety software

Description du poste

Manager, Pharmacovigilance & Medical Information – France

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.

Who You Are

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.

Required Skills

• 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.
• Ability to evaluate and interpret complex medical and scientific information.
• Strong understanding of PV quality and compliance requirements, including audit and inspection readiness.
• Excellent organizational skills, attention to detail and ability to ensure appropriate documentation, follow-up and archiving.
• Strong communication and stakeholder management skills, with the ability to work effectively in multidisciplinary and cross-functional teams.
• Ability to operate effectively with global teams, external partners and vendors.
• Proactive, adaptable, agile and responsive approach.
• Fluent in French and strong written scientific English, with the ability to read and prepare scientific documents, reports and communications.

Expected Educational Background

• Pharm.D or M.D.
• Minimum 4 years of professional experience in Pharmacovigilance and Medical Information.

Additional Employment Conditions

• Position based in France.
• Hybrid working model.
• The role combines approximately 50% global biosimilars Pharmacovigilance activities and 50% Biogen France Pharmacovigilance and Medical Information activities.

Job Level: Management

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.