Manager Clinical Safety (1-year maternity leave cover) Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID:10511 As 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. 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. 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