Clinical Safety Manager | Life Scientist (m/w/d)
BioNTech SE
Job Summary
As a Clinical Safety Manager, you will be instrumental in overseeing and managing clinical safety and pharmacovigilance activities throughout the entire lifecycle of clinical trials. Your daily responsibilities will involve leading safety planning and operational setup, serving 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. You will coordinate reporting of SUSARs to regulatory authorities, collaborate with Safety Physicians on medical reviews, and contribute to safety document development and SOP updates. This role is attractive due to its critical contribution to global clinical development, ensuring compliance with regulatory standards, and the opportunity to act as a Subject Matter Expert in a dynamic biotech environment.
Required Skills
Education
Advanced Degree in life sciences, pharmacy, public health, or a related field (PhD preferred)
Experience
- Minimum 3 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
- Minimum 1 year of case processing experience
Languages
Additional
- Not specified
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