Clinical Safety Specialist | Life Scientist (m/w/d)
BioNTech SE
Job Summary
As a Clinical Safety Specialist, you will play a crucial role in ensuring the safety of clinical trials by supporting pharmacovigilance activities throughout their lifecycle. Your daily tasks will involve end-to-end case processing, including data entry, MedDRA coding, and causality assessments, as well as coordinating case exchanges and tracking compliance. You will also contribute to preparing and reviewing regulatory submissions like SUSARs and DSURs, maintain accurate safety database records, and perform SAE reconciliation. This role requires close collaboration with Safety Physicians and Scientists to interpret safety data and ensure document consistency. The ideal candidate will possess a Bachelor's degree in life sciences and at least two years of experience in clinical safety or pharmacovigilance, with a strong understanding of regulatory requirements. This position offers an opportunity to contribute significantly to patient safety within a dynamic pharmaceutical environment, with a focus on professional growth and work-life balance.
Required Skills
Education
Bachelor’s Degree in life sciences, pharmacy, public health or a related field (postgraduate qualification preferred)
Experience
- Minimum 2 years of experience in clinical safety and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
- Minimum 1 year of case processing experience
Languages
Additional
- Knowledge of applicable regulatory, GCP, and GVP requirements in major geographies
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