Head of TA, ExpMed

该职位是高级患者安全医师，负责全球药物安全策略制定、风险最小化活动及跨职能团队领导，需具备医学博士背景和药物警戒经验，在高不确定性环境中做出关键医疗决策，具有高业务影响

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; 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) and Clinical Overview Reports; Leads the BI-internal, cross-functional Asset Benefit Risk Team; Contributes to the ongoing strategic development of patient safety and pharmacovigilance at BI; Provides updates on the safety profile of the assigned medicinal product to senior management and recommends pharmacovigilance and risk management activities; Represents global pharmacovigilance in internal and external committees and bodies; Leads strategic projects, such as future digital solutions and strategic initiatives; Contributes to the ongoing strategic development of patient safety and pharmacovigilance at BI.