Manager Safety Operations
Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 11010
About the role
As a Safety Operations Manager, you will play a key role in managing safety operations 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
- Main contributor to the safety and operational set-up, conduct and close-out for clinical trials, including trial-specific plans, charters, and data transfer strategies.
- Develop and review safety documents (e.g., Safety Management Plans, DSURs) and contribute to process improvements.
- Act as the primary safety operations contact for assigned trials, ensuring timely execution of safety deliverables and oversight of IMP-related activities.
- Oversee and conduct 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.
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. (Post-marketing experience is a plus).
- Strong knowledge of GCP, GVP, and regulatory requirements.
- Strong scientific writing, project management, and collaboration skills.
- Fluent in English (written and spoken).
Your Benefits:
BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.
How to apply:
Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
Please note:
Only applications sent via our online form shall be considered. 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.
We are looking forward receiving your application.