Clinical Safety Manager | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This crucial role involves overseeing clinical safety and pharmacovigilance activities across clinical trials, ensuring strict compliance with global regulations and internal quality standards to safeguard patient safety. Day-to-day responsibilities include leading safety planning and operational setup for trials, acting as the primary safety contact, and supervising end-to-end Individual Case Safety Report (ICSR) processes, including MedDRA coding and causality assessments. The manager will also coordinate SUSAR reporting to regulatory authorities and Ethics Committees, support Safety Physicians in medical review, and contribute to the development and review of key safety documents like DSURs and Safety Management Plans. Candidates must possess an advanced degree in a life science field (PhD preferred) and have a minimum of three years of relevant pharmacovigilance experience. This position, offered as a one-year maternity leave cover, requires fluency in English and strong knowledge of GCP and GVP, offering an opportunity to make a pivotal impact on global health initiatives.
Required Skills
Education
Advanced degree in life sciences, pharmacy, public health, or related field (PhD preferred)
Experience
- Minimum 3 years of clinical research and pharmacovigilance experience
- Minimum 2 years of case processing experience
Languages
Additional
- 1-year maternity leave cover (Fixed-term contract)
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