Global Head of Clinical Safety

About the role

Galderma is opening a new Global Capability Center in Barcelona and is looking for a Global Head of Clinical Safety. You will provide medical safety expertise for the benefit/risk assessment of products in clinical development, with a focus on the key biologic Nemolizumab, including signal detection, risk management plans, safety analyses in aggregate reports and input into publications and data dissemination. The role also covers the medical review of safety-related information in study protocols, reports, investigator brochures, product labelling (including CCDS), periodic and aggregate reports, and risk management plan responses to health authority questions. It reports to the Global Head of Pharmacovigilance Risk Management, lines manages a team of up to 5 PV staff worldwide, and offers relocation support from within the EU/UK.

Key responsibilities

• Propose and recommend measures to minimize risks during clinical development and release and update Development Risk Management Plans (DRMPs)
• Monitor the safety profile of assigned compounds with partners, validate and evaluate signals, and propose risk management and minimization measures
• Own aggregate safety reports (DSUR, PSUR, PBRER) and development Risk Management Plans (RMP)
• Contribute to dossier submissions, answers to regulatory questions, investigator/KOL meetings and IDMC meetings
• Lead safety data reviews during clinical trials through Safety Plans and review meetings, and escalate safety issues to company governance bodies
• Support compliance and PV inspection/audit activities and collaborate with Global Regulatory Affairs, Global Medical Affairs, Clinical Development, Commercial and other stakeholders

Required profile

• Doctor of Medicine (M.D.) required
• 12 years of experience in a global clinical safety/pharmacovigilance role (drug development focus) in an ethical pharmaceutical company
• 3 to 5 years of line management experience of a team of Safety Physicians and/or Scientists
• Preferred: additional degree in clinical pharmacology, pharmacovigilance/drug safety, epidemiology or a related field

Required skills

• Knowledge of international clinical development and post-marketing regulations for drugs, and of biologic development regulations and best practice
• Experience addressing safety questions with health authorities in the US, EU and other regions
• Sound knowledge of global pharmacovigilance and safety requirements for non-clinical and clinical development, registration and post-marketing

What we offer

• Competitive compensation with bonus structure and extended benefits
• Hybrid work culture
• Personalized career path through feedback loops
• Relocation support from within the EU/UK for the right candidate