Global Patient Safety Asset Lead, Rare Diseases
HybridLondon, England, United Kingdom or Paris, Île-de-France, France
Job Summary
Lead proactive safety and risk management strategies for assigned rare disease products, integrating clinical development and life-cycle management plans. Ensure timely proposal of safety profile changes and appropriate risk minimization actions while supporting benefit-risk assessment decisions. Provide expertise for regulatory submissions, periodic safety reports, and health authority meetings, including signal detection and evaluation. Represent Global Patient Safety at internal and external meetings, collaborate with cross-functional teams, and conduct TA-specific training for vendors and internal staff.
Required Qualifications
- MD
- several years of clinical experience exercising medical judgment as a physician
- Pharmaceutical industry experience in clinical development
- Experience in leading Cross functional Global Product Teams, Safety Teams and Clinical Development Teams
- Knowledge of product development processes
- experience of cross-functional teamwork
- Working knowledge of pharmacovigilance legislations worldwide
- Prior experience with NDA/BLA or equivalent regulatory submissions
- experience working in a Regulatory Agency reviewing submission file
- Fluent in English
Desired Qualifications
- Experience in leading Safety Teams
- Experience in leading Clinical Development Teams
- additional European language such as French
- Experience in leading Cross functional Global Product Teams, Safety Teams and Clinical Development Teams
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