Manager, Clinical Safety (Maternity Cover) | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This role as a Clinical Safety Manager is a critical 1-year maternity cover position focused on overseeing clinical safety and pharmacovigilance activities during clinical trials. Based across multiple potential locations including Mainz, London, and Munich, the incumbent will ensure strict compliance with global regulations (GCP, GVP) and internal quality standards, directly contributing to patient safety. Day-to-day responsibilities involve leading safety planning, acting as the primary safety contact for assigned trials, and supervising end-to-end Individual Case Safety Report (ICSR) processes, including MedDRA coding and causality assessments. A key function is coordinating SUSAR reporting to regulatory authorities and contributing to safety documentation like DSURs. The ideal candidate must hold an advanced degree in life sciences or a related field, possess a minimum of three years of clinical research and pharmacovigilance experience, and be fluent in English. This position offers the opportunity to act as a Subject Matter Expert during audits and inspections, driving process improvements within a mission-driven global health organization.
Required Skills
Education
Advanced degree in life sciences, pharmacy, public health, or related field (PhD preferred)
Experience
- Minimum 3 years in clinical research and pharmacovigilance
- Minimum 2 years of case processing experience
- Professional experience leading safety planning and operational set-up for clinical trials
- Professional experience coordinating SUSAR reporting to regulatory authorities
Languages
Additional
- 1-year maternity leave cover (fixed-term position)
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