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Head of Medical Safety GCSP

Bavarian Nordic · Berne

Senior 🇬🇧 English
GCP GVP ICH guidelines CTD compilation IT tools database applications

Job description

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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Published 4 months ago

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Bavarian Nordic

Berne