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Safety Operations Specialist
BioNTech SESafety Operations Specialist at BioNTech supporting pharmacovigilance activities across clinical trials and post-marketing phases. Ensuring compliance with global safety standards and coordinating regulatory submissions.
Tech Stack
Tools & technologiesGoogle Cloud PlatformVault
About the role
Key responsibilities & impact- Perform and support end-to-end case processing activities for clinical trials, including intake, data entry, triage, MedDRA coding, seriousness evaluations, case approval, and safety queries
- Support case processing for post-marketing ICSRs, including monitoring spontaneous reports and other safety data sources
- Coordinate case exchanges with partners and track compliance metrics for safety reports through continuous quality control sampling
- Prepare and conduct quality reviews for SUSAR submissions, DSURs, line listings, and other periodic reports in line with global requirements
- Execute and maintain workflows such as regulatory reporting, safety inbox screening/intake, data reconciliation, or analytical report generation based on assigned responsibilities
- Maintain accurate records within the safety database and assist with system testing activities (e.g., user acceptance testing)
Requirements
What you’ll need- Bachelor’s degree in life sciences, pharmacy, public health or a related field; postgraduate qualification preferred
- At least 2 years of pharmacovigilance experience in the pharmaceutical/biotech/CRO industry; post-market setting preferred
- Minimum 1 year of case processing experience; familiarity with Veeva Vault Safety is ideal
- Solid knowledge of regulatory requirements (GCP/GVP) across major geographies
- Strong project management skills combined with cross-functional collaboration abilities
- Fluent in written and spoken English
Benefits
Comp & perks- flexible hours
- vacation account
- Digital Learning
- Performance & talent development
- leadership development
- Apprenticeships
- LinkedIn Learning
- Company bike
- Job ticket
- Deutschlandticket
- Employer-funded pension
- Childcare
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
case processingdata entryMedDRA codingseriousness evaluationsregulatory reportingdata reconciliationanalytical report generationquality reviewsuser acceptance testing
Soft Skills
project managementcross-functional collaboration
Certifications
Bachelor’s degreepostgraduate qualification