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.
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.
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
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