Associate Director Clinical Safety Management (m/w/d)
Mainz, Germany | full time | Job ID: 9007
As 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.
Your main responsibilities are:
- 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 BioNTech’s Safety Surveillance Teams (SST) and Safety Management Teams (SMT), including meetings to ensure consistent safety oversight, data provision, and decision-making for assigned compounds.
- Drive the development, implementation, and continuous improvement of 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 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 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, and GVP requirements in key geographies
- Experience overseeing safety database functionality and configuration, including coordination with internal stakeholders and external vendors
- Strong computer proficiency, including experience with safety database set-up and data visualization tools
- 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
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9007 (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.