Manager Clinical Safety (1-year maternity leave cover)
Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:10511As a Clinical Safety Manager, you will oversee clinical safety and pharmacovigilance activities throughout clinical trials, ensuring compliance with global regulations and BioNTech’s quality standards. Your work will be pivotal in safeguarding patient safety and advancing our mission to improve global health.
Responsibilities:
- 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.
What you have to offer:
- 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).
- 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!
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.
Inspired? Become part of #TeamBioNTech.
BioNTech, the story
At BioNTech, we are more than just a biotechnology company - we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases.
Experience a dynamic workplace that embraces diversity in all its forms. We foster innovation, encourage creativity, and develop business strategies driven by our shared passion for advancing medicine.
Working at BioNTech means striving to achieve medical breakthroughs while growing your career in a meaningful way. Apply today and become part of a mission that has the potential to change lives around the world.
BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, personal orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!
BioNTech - As unique as you