As a Safety Operations Specialist, you will play a pivotal role in supporting pharmacovigilance activities across clinical trials and post-marketing phases. Your contributions will ensure compliance with global safety standards while gaining valuable experience in safety operations. You will work closely with cross-functional teams to process individual case safety reports (ICSRs), coordinate regulatory submissions, and maintain workflows critical to BioNTech’s mission of advancing healthcare solutions.
Your Contribution:
* 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)
A good Match:
* 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
Your Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our London, United Kingdom; Mainz, Germany; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11418 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.