Position Summary
We are seeking a seasoned and strategic leader to join our Global Medical Safety (GMS) organization. This role is accountable for guiding the development and execution of benefit-risk assessments, proactive risk management strategies, and safety evidence generation. As a key member of the GMS leadership team, the successful candidate will influence the strategic direction of the function, drive cross-functional initiatives, and ensure the highest standards of quality, compliance, and ethics across safety processes.
Key Responsibilities
* Motivate, direct, challenge, and advise Leads, Scientists, and senior governance bodies in designing and implementing best-in-class safety strategies and benefit-risk evaluations.
* Review and sign off on safety-related communications and documentation intended for external stakeholders, acting as a delegate for senior safety leadership.
* Represent the safety function in high-level internal and external forums, including cross-functional committees, regulatory meetings, and scientific advisory panels focused on benefit-risk discussions.
* Lead and contribute to strategic projects and initiatives across safety and related functional areas, supporting corporate goals and innovation.
* Participate in setting the strategic direction of the Global Medical Safety function, contributing to both functional and enterprise-level priorities.
* Act as Global Process Owner for key pharmacovigilance and patient safety processes, ensuring alignment with regulatory expectations and internal standards.
* Stay current with evolving regulatory landscapes, scientific advances, and societal trends to support innovation and continuous improvement in patient safety practices.
Qualifications
What you bring to the team
Our preferred candidate has the following qualifications:
* Degree as Medical Doctor or PhD within Life Science
* 10-15+ years’ pharma experience within Patient Safety & Pharmacovigilance, Clinical Development, Medical Affairs, Regulatory Affairs, including experience with safety evidence generation and risk minimization strategies, and benefit risk assessments
* Extensive people leadership experience with a successful track record in setting strategic direction and delivering on Corporate and functional objectives, including cross-functional ones
* Experience with supporting teams in regulatory interactions, DMCs, inspections/audits, Business Development evaluations, scientific meetings with external stakeholders (e.g. pre-NDA meeting, FDA Advisory Committee meeting, (Patient Organisation) Advisory Boards etc.)
* Excellent medical-scientific knowledge and ability to make sound medical decisions in an environment of high uncertainty and with critical impact for patients’ well-being
* Profound knowledge and understanding of medical concepts and scientific methodology
* Excellent understanding of early and late clinical development, as well as global PV regulatory environment
* Experience with global filings in US, EU, Japan and China
* Experience in neuroscience and/or with biological compounds would be an asset
* Digitally savvy and fluent in English, both written and spoken
* Thought leadership and source of inspiration for co-workers, irrespective of functional affiliation
* Curiosity, persistence and willingness to go into (scientific) details and constructively challenge status quo
* Customer-centric approach, being able to understand both internal and external customer needs and deliver value adding outcomes with high quality, on time and in a resource efficient manner
* Proactivity proposing creative, practical and scientifically solid solutions for complex problems
* Innovative mindset motivated by outgoing cross-functional collaboration and the ability to influence and interact effectively with internal and external stakeholders
* Ability to work structured, independently and effectively across functions and geographies
* Team player with good interpersonal skills including excellent communication, messaging and presentation skills
* Motivated by scientific challenges, rather than by organizational power
* Pronounced strengths in strategic thinking
* Proficient servant leader with demonstrated ability to build diverse and empowered teams based on the concepts of psychological safety and agile ways of working