Original Beschreibung
# Manager Clinical Safety (m/w/d)
Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 9158
As a Clinical Safety Manager, you will manage clinical safety and pharmacovigilance activities throughout the lifecycle of clinical trials. Core responsibilities include oversight of clinical trial activities, end-to-end case processing including safety reporting and safety data review and analysis.
**Your main responsibilities are:**
• Lead safety planning and operational set-up activities during the set-up, conduct and close out of clinical trials including the development and alignment of trial specific plans, charters, reconciliation and data transfer strategies. Coordinate with cross-functional stakeholders to ensure safety data collection, reporting, and review.
• Serve as the primary clinical safety contact for assigned clinical trials, ensuring timely execution of trial-specific safety deliverables, may oversee activities related to specific IMPs.
• Supervise end-to-end ICSR processes: case triage, MedDRA coding, causality and seriousness assessments, and safety query resolution. Oversee internal and vendor-submitted cases to ensure accurate and timely entry into the safety database, aligned with BioNTech’s SOPs and global timelines.
• Coordinate reporting responsibilities for SUSARs and other reportable events across BioNTech’s clinical development portfolio. Ensure submission to regulatory authorities (e.g., MHRA, EMA, FDA) and Ethics Committees via appropriate channels and maintain oversight of CRO-submitted reports.
• Work closely with Safety Physicians to support the medical review of safety cases, contribute to safety data interpretation, and ensure consistency and accuracy in trial-specific documents such as clinical trial protocols and regulatory responses.
• Contribute to the development and review of safety related documents (e.g., Safety Management Plans, Reconciliation Plans, structured Benefit-Risk Assessments), and coordinate preparation of periodic safety reports (e.g., DSURs) in collaboration with cross-functional teams.
• Contribute to updates of key standard operating procedures (SOPs) related to safety processes, ensure all safety management activities align with BioNTech’s quality standards, global regulations, and ethical requirements, and act as a Subject Matter Expert during audits and inspections for core safety processes.
**What you have to offer:**
• Advanced Degree in life sciences, pharmacy, public health or a related field (PhD preferred)
• Minimum 3 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry
• Minimum 1 year of case processing experience
• Strong knowledge of applicable regulatory, GCP, and GVP requirements in key geographies
• Strong scientific writing, project management, and cross-functional collaboration skills
• 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
**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, 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!
**BioNTech - As unique as you**