Senior Safety Scientist | Life Scientist (m/w/d)
BioNTech SE
Job Summary
The Senior Safety Scientist provides crucial scientific and strategic expertise for clinical development programs, focusing heavily on compound-level safety surveillance and risk management. Daily tasks involve leading the preparation of periodic safety reports (such as DSURs), conducting safety database analyses, and authoring critical trial-related documentation, including Safety Management Plans and structured Benefit-Risk Assessments. The role requires partnering closely with safety physicians to review clinical trial protocols and statistical outputs, and acting as the primary scientific point of contact for clinical safety teams. A key aspect is driving the development and continuous improvement of safety signal processes, overseeing surveillance across multiple clinical programs, and leading Safety Surveillance Teams. This position is attractive due to its high level of responsibility in ensuring global regulatory compliance (GCP/GVP), acting as a Subject Matter Expert during audits, and offering the opportunity to build specialized expertise in areas like data analytics and signal detection within a leading biotech company.
Required Skills
Education
Advanced Degree in life sciences, pharmacy, public health, or a related field (PhD preferred)
Experience
- Minimum 5 years in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
- Experience including case processing activities
- Experience in designing and implementing clinical safety processes, support systems, and tools
- Professional experience acting as a Subject Matter Expert during audits and inspections
Languages
Additional
- Must be able to work across key geographies (Mainz, London, Munich). Requirement to manage and update key Standard Operating Procedures (SOPs). Must ensure all safety management activities align with global regulations and ethical requirements.
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