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Head of Medical Safety – Global Clinical Safety & Pharmacovigilance

Bavarian Nordic · Martinsried

Neu
Senior 🇬🇧 English
GCP GVP ICH guidelines CTD compilation

Stellenbeschreibung

About the role

We are seeking a senior leader to head Medical Safety within our Global Clinical Safety & Pharmacovigilance (GCSP) function. Reporting to the Head of GCSP & EU/UK QPPV, the role will be based in Germany or Switzerland and will involve up to 20 % travel across Europe. The successful candidate will provide medical leadership, oversee safety activities for both development programs and marketed products, and drive innovation in safety processes.

Key responsibilities

  • Lead, develop and mentor a team of six senior Safety Physicians and Scientists.
  • Ensure high‑quality clinical safety contributions throughout product life‑cycle in line with regulations, company SOPs and global guidelines.
  • Represent the GCSP function on leadership and governance committees.
  • Support GCP and GVP audits and inspections, providing medical safety expertise.
  • Contribute to strategic initiatives, innovation projects and the adoption of new safety technologies.
  • Stay current with emerging regulations, tools and best practices in medical safety.

Required profile

  • Medical Doctor (MD) degree with at least 10 years of experience in clinical safety and pharmacovigilance, including senior medical safety roles.
  • Proven leadership experience, ability to set direction and drive high‑performing teams in a regulated, global environment.
  • Strong ethical judgment, stakeholder engagement skills and resilience in change‑driven settings.
  • Fluent English communication, both written and oral, with ability to present complex medical and regulatory information.

Required skills

  • Deep knowledge of GCP, GVP and ICH guidelines.
  • Hands‑on experience with CTD compilation and MAA/BLA submissions to major health authorities.
  • Expertise in signal management, risk minimisation and global safety regulations.
  • Proficiency with relevant IT tools and safety databases.

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Veröffentlicht vor 4 Tagen

Läuft ab in 1 Monat

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Bavarian Nordic

Martinsried