Global Head of Clinical Safety
Galderma
Pharmazeutische Industrie
Barcelona, Cataluña - Spanien
Abteilungsleiter / Manager
Hybrid
Experteer Overview
As Global Head of Clinical Safety, you will provide medical safety leadership for product development and life-cycle safety in dermatology, focusing on Nemolizumab. You will guide risk management, signal detection, and safety analyses, while shaping regulatory inputs and PV partnerships. You’ll lead a global PV team and collaborate with regulatory, medical affairs, and development functions. Your work helps ensure safe, meaningful outcomes for patients with skin conditions, aligning with Galderma’s mission to advance dermatology for every skin story.
Leistungen / Benefits
- competitive compensation package
- bonus structure
- extended benefit package
- hybrid work culture
- personal career development
- diversity & inclusion
Verantwortungsbereiche
- Propose and implement risk-minimization measures during clinical development and maintain DRMPs
- Monitor safety profiles, validate signals, and recommend risk management actions with internal/external stakeholders
- Own aggregate safety reports (DSUR, PSUR, PBRER) and develop Risk Management Plans (RMP)
- Contribute to safety modules for regulatory submissions and respond to safety questions from authorities
- Lead and line-manage a PV team across locations, supporting clinical development and lifecycle safety
- Engage in safety reviews during trials through Safety Plans and governance meetings
- Present safety issues to governance bodies and support PV inspections/audits
- Collaborate with Global Regulatory, Medical Affairs, Clinical Development, and Commercial teams
- Support IDMC meetings, due diligence activities, and safety communications to investigators/KOLs
- Contribute to publications, data dissemination, and health authority interactions
- Provide input on safety-related investigations and risk assessments for biologics
Zentrale Anforderungen
- MD degree with extensive global clinical safety/pharmacovigilance experience
- 12+ years in pharmaceutical safety, with drug development emphasis
- 3–5+ years of line management experience in safety physicians/scientists
- Strong knowledge of international clinical development, post-marketing regulations, and biologics guidance
- Experience addressing safety questions from US/EU/global health authorities
- Knowledge of regulatory safety modules and RMPs across development stages
- Additional degree in clinical pharmacology/pharmacovigilance/epidemiology preferred
Stellenbeschreibung
As Global Head of Clinical Safety, you will provide medical safety leadership for product development and life-cycle safety in dermatology, …
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