Manager Clinical Safety (1-year maternity leave cover)

Manager Clinical Safety (1-year maternity leave cover)

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.

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.

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 years 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 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 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) -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.

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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, sexual 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!