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Scientific Director – Safety Evaluation & Risk Management

GSK · Wavre

Senior 🇬🇧 English
Pharmacovigilance Risk Management Planning Regulatory submissions

Job description

About the role

The SERM Scientific Director will lead safety evaluation and risk‑management activities for GSK’s global portfolio of medicines and vaccines. Reporting to senior safety leadership, you will ensure scientifically sound interpretation of safety data, drive benefit‑risk assessments, and support regulatory submissions across clinical development and post‑marketing phases.

Key responsibilities

  • Develop and execute pharmacovigilance and risk‑management plans for assigned assets.
  • Lead the safety component of global regulatory submissions and interact with health authorities.
  • Conduct literature reviews, synthesize clinical data, and provide expert analysis of safety signals.
  • Drive safety governance by defining strategy, monitoring product incidents, and communicating risk mitigation actions.
  • Escalate critical safety issues to senior management and safety committees as required.

Required profile

  • Advanced degree (PhD, MD, or equivalent) in a relevant scientific discipline.
  • Extensive experience in pharmacovigilance, benefit‑risk assessment, and regulatory affairs.
  • Proven track record of high‑quality decision‑making in a global pharmaceutical environment.
  • Strong analytical thinking and ability to prioritize multiple safety projects.

Required skills

  • Pharmacovigilance
  • Risk Management Planning
  • Regulatory submissions
  • Clinical data analysis

What we offer

  • Opportunity to influence the safety profile of medicines impacting billions of patients.
  • Collaborative, science‑driven culture within a leading global pharma company.
  • Competitive compensation and benefits package.

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Published 2 maanden geleden

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GSK

Wavre