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BioNTech SE
Biologist as Associate Director (m/f/d)
• Mainz, 55131
Führungs-/ Leitungspositionen Homeoffice möglich
Jobticket
Associate
Director Clinical Safety Management (m/w/d) Mainz, Germany; London, United Kingdom; Munich, Germany full time Job ID:9007As Associate Director Clinical Safety Management, you will provide scientific and strategic expertise to our clinical
development programs. Core responsibilities include safety data review, periodic report preparation, and global safety database oversight. Provide expert scientific input to clinical safety activities, including safety database analysis, authoring and reviewing study-related documents (e. g. , Safety Management Plans, Reconciliation Plans, structured Benefit-Risk Assessments) , and leading the preparation of periodic safety reports (e. g. , DSURs) in collaboration with cross-functional teams. Partner with safety physicians to review and contribute to safety-relevant sections of clinical trial protocols, investigator brochures, clinical study reports, and statistical outputs (tables, figures, listings) , and to co-author relevant safety documentation for BioNTech compounds. Actively lead or contribute to BioNTechs Safety Surveillance Teams (SST) and Safety Management Teams (SMT) , including meetings to ensure consistent safety oversight, [...] safety database processes. Oversee and enhance strategies and business processes including system configuration, vendor collaboration, and alignment of internal safety processes. Serve as primary scientific point of contact for clinical safety team members including best practice approaches, project-specific mentoring and
training. Support collaboration by providing training and scientific guidance on safety management practices to colleagues in cross-functional departments. Build subject matter expertise in focus areas such as data analytics, analytical report outputs, safety database configurations or signal detection. Manage and update key standard operating procedures (SOPs) related to safety processes, ensure all safety management activities align with BioNTechs 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 5 years of experience in clinical research and pharmacovigilance within the pharmaceutical, biotech, or CRO industry, including case processing activities Strong knowledge of applicable regulatory, GCP, [...]
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