Head of Medical Safety GCSP

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. The role As our Head of Medical Safety GCSP, you will be 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. In this role, you will manage and mentor a team of six (Sr) Safety Physicians and (Sr) Safety Scientists. Key responsibilities

What you bring To become a success in this role, you bring a Medical Doctor (MD) degree combined with leadership experience within clinical safety and pharmacovigilance. You are recognized for setting direction, taking accountability, and leading teams with passion, clarity and empathy in a highly regulated, global environment. You balance strategic oversight with confident decision?making and strong ethical stakeholder engagement.

You bring solid knowledge of global clinical safety and pharmacovigilance regulations including GCP, GVP, and ICH guidelines, along with hands-on experience in CTD compilation and MAAs/BLAs submissions to major health authorities. Besides this, you communicate fluently in English with solid written, verbal, and presentation skills using medical and regulatory terminology. You are highly proficient in relevant IT tools and database applications and are a self-driven, positive team player who helps to build and sustain high performance and team cohesion. Most importantly, you thrive in change; your judgment, integrity, and resilience help safeguard patient safety and support our transition from development to full commercialization in a fast-moving, life-science environment. Please note an advanced degree is required, and an MD qualification is mandatory for this role. Why this role 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. It is a role with both strategic impact and hands?on responsibility, ideal, if you want to grow your expertise while making a meaningful difference. In this role, you will have the platform to make a lasting impact on public health, advance our mission, and set new benchmarks for medical excellence in a dynamic, growth-oriented biotechnology environment. Application If you are ready to take on a pivotal role in a growing organization and drive meaningful change in healthcare, apply now and join Bavarian Nordic in our mission to improve health outcomes and foster sustainable growth. Please note that we do not support any relocation package for this role. We kindly request that headhunters or recruitment agencies refrain from contacting us regarding this position. Bavarian Nordic is a global vaccine company with a mission to improve health and save lives through innovative vaccines. We are a preferred supplier of mpox and smallpox vaccines to governments to enhance public health prepare

• Lead and develop the medical safety team and ensure that appropriate tools and skillsets are available/developed
• Ensure high quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, 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
• 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