Senior Safety Scientist | Pharmacist (m/w/d)
BioNTech SE
Job Summary
As a Senior Safety Scientist, you will be instrumental in providing scientific and strategic expertise to clinical development programs, focusing on safety data review, periodic report preparation, and comprehensive safety surveillance. Day-to-day, you will offer expert scientific input to clinical safety activities, author and review trial-related documents, and lead the preparation of critical safety reports. You will also partner with safety physicians to review clinical trial protocols and co-author safety documentation. This role involves driving the development and continuous improvement of safety signal processes, overseeing safety surveillance across clinical programs, and actively contributing to Safety Surveillance and Management Teams. You will also serve as a primary scientific point of contact, provide training and guidance on safety management, and act as a Subject Matter Expert during audits. This position offers a unique opportunity to shape and impact critical safety processes within a dynamic biotech environment.
Required Skills
Education
Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred)
Experience
- Minimum 5 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
- Experience in case processing activities
- Strong knowledge of applicable regulatory, GCP, and GVP requirements in key geographies
- Experience in designing and implementing clinical safety processes, support systems, and tools
Languages
Additional
- Not specified
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