About this role
The Senior Patient Safety Physician (Senior PSP) is an experienced medical expert with a solid clinical and scientific background, combined with extensive experience in pharmacovigilance and a commitment to patient safety. The Senior PSP holds full medical and strategic overall responsibility for benefit-risk and product risk minimization activities for products under development on a global level and with high business impact. The Senior PSP contributes to defining the strategic objectives of the assigned programs within patient safety and pharmacovigilance and oversees their patient safety-related implementation across the various medical functions.
This position reports to the Head of TA ExpMED China. Develops proactive risk management strategies for key products under development. Develops, monitors, and updates the patient safety strategy in the context of holistic evidence generation for the assigned products and programs.
Plans, manages/conducts, and monitors all pharmacovigilance activities for the assigned drug safety responsibilities, including: Full responsibility for the development, continuous monitoring, and updating of the benefit-risk profile of assigned products, as well as medical assessment with high business impact. Continuous monitoring and further development of the product safety profile. Detection and evaluation of safety signals as well as management of safety issues.
Establishment of safety analyses in clinical study databases. Close collaboration with TA Medicine, Global Regulatory Affairs, Global Epidemiology & Medical Affairs, and Global Biostatistics & Data Sciences on safety-oriented clinical and epidemiological studies. Authoring, reviewing, and providing medical-scientific input to regulatory documents such as: Development Safety Update Reports (DSUR) Clinical Overview Reports Leads the BI-internal, cross-functional Asset Benefit Risk Team, comprising experts from TA Medicine, Pharmacovigilance, Medical Affairs, Global Regulatory Affairs, Epidemiology, and Biostatistics & Data Sciences, as well as other relevant disciplines.
Contributes to the ongoing strategic development of patient safety and pharmacovigilance at BI by staying current on state-of-the-art methods, changes in the regulatory landscape, and developments and trends in the healthcare system and society. Provides updates on the safety profile of the assigned medicinal product to senior management and recommends pharmacovigilance and risk management activities to BI's decision-making bodies and the EU-QPPV. Represents global pharmacovigilance in internal and external committees and bodies, including leading and steering relevant discussions on product benefit-risk assessments (e.g., in FDA advisory committees, patient organizations).
Leads strategic projects, such as future digital solutions, strategic initiatives, and navigating the changing global regulatory environment. Contributes to the ongoing strategic development of patient safety and pharmacovigilance at BI by staying current on state-of-the-art methods, changes in the regulatory landscape, and developments and trends in the healthcare system and society. Requirements MD with 5–10 years of prior experience in medical functions, including at least 2–5 years of patient safety and pharmacovigilance (PSPV) experience Sound clinical and scientific experience Excellent ability to make well-founded medical decisions in an environment of high uncertainty and with critical implications for the company and patient well-being Proven leadership potential Negotiation and influencing skills Strong cross-functional collaboration competencies Project management competencies Excellent interpersonal and communication skills Excellent command of English