At Bavarian Nordic, we are committed to saving and improving lives by unlocking the power of the immune system. Our commercial portfolio includes market-leading vaccines against smallpox/mpox, rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization—working every day to protect people’s health and quality of life and protecting our tomorrow.
We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). The position reports to the Head GCSP & EU/UK QPPV and can be based in either Germany or Switzerland. Travel up to ~20% within Europe should be expected.
Tasks
- Accountable for all medical safety related aspects of clinical safety and pharmacovigilance as well as ad hoc safety issues and innovation projects in your area of expertise.
- Manage and mentor a team of six (Sr) Safety Physicians and (Sr) Safety Scientists.
- Lead and develop the medical safety team and ensure that appropriate tools and skillsets are available or developed.
- Ensure high quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, and BN operating procedures (SOPs).
- Serve as member of the GCSP Leadership Team and in governance committees as assigned.
- Ensure medical safety support for GCP and GVP audits and inspections.
- Contribute to company strategic initiatives and innovations.
- Stay abreast of innovative technologies, tools, innovations, and regulations concerning area of expertise.
Requirements
- Medical Doctor (MD) degree is mandatory; advanced degree required.
- Leadership experience within clinical safety and pharmacovigilance.
- 10+ years of experience across clinical safety and pharmacovigilance, including senior Medical Safety roles.
- Deep regulatory expertise across global safety activities, including signal management and risk minimization.
- Solid knowledge of global clinical safety and pharmacovigilance regulations including GCP, GVP, and ICH guidelines.
- Hands-on experience in CTD compilation and MAAs/BLAs submissions to major health authorities.
- Fluent communication in English with solid written, verbal, and presentation skills using medical and regulatory terminology.
- Highly proficient in relevant IT tools and database applications.
- Self-driven, positive team player who helps to build and sustain high performance and team cohesion.
- Ability to thrive in change; strong judgment, integrity, and resilience to safeguard patient safety and support transition from development to full commercialization in a fast-moving, life-science environment.
- Recognized for setting direction, taking accountability, and leading teams with passion, clarity, and empathy in a highly regulated, global environment.
- Balance strategic oversight with confident decision-making and strong ethical stakeholder engagement.
Benefits
This role offers a unique opportunity to take end-to-end responsibility for all medical safety activities within clinical safety and pharmacovigilance in a science-driven organization with a strong purpose. You will mentor a team, work closely with global stakeholders, contribute directly to regulatory submissions and patient safety, and have real influence on how safety processes and risk management activities are shaped and executed. The role has both strategic impact and hands-on responsibility, providing the platform to make a lasting impact on public health and set new benchmarks for medical excellence in a dynamic, growth-oriented biotechnology environment.
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Über uns
Das Team
You will manage and mentor a team of six (Sr) Safety Physicians and (Sr) Safety Scientists and serve as a member of the GCSP Leadership Team.