Head of Medical Safety GCSP
Bavarian Nordic · Berne
Description du poste
About the role
Bavarian Nordic seeks an experienced Head of Medical Safety GCSP to provide medical leadership across Global Clinical Safety & Pharmacovigilance. Reporting to the Head GCSP & EU/UK QPPV, the role can be based in Germany or Switzerland and involves up to 20% travel within Europe.
Key responsibilities
- Lead, develop and mentor a team of six senior Safety Physicians and Scientists.
- Ensure high‑quality clinical safety contributions for development programs and lifecycle management of marketed products, complying with regulations, guidelines and internal SOPs.
- Participate as a member of the GCSP Leadership Team and serve on assigned governance committees.
- Provide medical safety support for GCP and GVP audits and inspections.
- Contribute to strategic initiatives, innovation projects and stay current on emerging technologies, tools and regulations.
Required profile
- Medical Doctor (MD) degree with extensive leadership experience in clinical safety and pharmacovigilance.
- 10+ years of experience in senior medical safety roles, including signal management and risk minimization.
- Deep regulatory expertise across global safety activities and hands‑on experience with CTD compilation and MAA/BLA submissions.
- Fluent English with strong written, verbal and presentation skills using medical and regulatory terminology.
- Self‑driven, resilient and able to thrive in a changing, highly regulated global environment.
Required skills
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice (GVP)
- ICH guideline knowledge
- CTD compilation
- MAA/BLA submission experience
- Proficiency with IT tools and database applications
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Bavarian Nordic
Berne
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