Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 10511
About the role
As a Clinical Safety Manager, you will play a key role in managing clinical safety and pharmacovigilance activities across clinical trials, ensuring adherence to global regulations and BioNTech’s established quality standards. Your expertise will contribute to maintaining the highest standards of patient safety while supporting the development of innovative therapies. This position offers the opportunity to make a meaningful impact on advancing BioNTech’s mission to deliver groundbreaking solutions that improve health outcomes worldwide.
Your Contribution
• Lead safety planning and operational set-up for clinical trials, including trial-specific plans, charters, and data transfer strategies.
• Act as the primary safety contact for assigned trials, ensuring timely execution of safety deliverables and oversight of IMP-related activities.
• Supervise end-to-end ICSR processes, including case triage, MedDRA coding, causality assessments, and vendor oversight.
• Coordinate SUSAR reporting to regulatory authorities and Ethics Committees, ensuring compliance with global timelines.
• Support Safety Physicians in medical review, safety data interpretation, and trial-specific documentation.
• Develop and review safety documents (e.g., Safety Management Plans, DSURs) and contribute to process improvements.
• Ensure alignment with regulatory standards and act as a Subject Matter Expert during audits and inspections.
A good match
• Advanced degree in life sciences, pharmacy, public health, or related field (PhD preferred).
• Minimum 3 years of clinical research and pharmacovigilance experience, including 2 year of case processing.
• Strong knowledge of GCP, GVP, and regulatory requirements.
• Excellent scientific writing, project management, and collaboration skills.
• Fluent in English (written and spoken).
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 Mainz, Germany; London, United Kingdom; 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 10511 (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.