Director Drug Safety, Individual Case Medical Review page is loaded Director Drug Safety, Individual Case Medical Review Apply remote type Hybrid locations CZE - Central Bohemian - Prague (Five) POL - Mazowieckie Wojewodztwo - Warsaw (Trade Center) time type Full time posted on Posted Yesterday time left to apply End Date: December 31, 2025 (30+ days left to apply) job requisition id R347908 Job Description The Director provides dynamic leadership and strategic direction with regards to high quality and excellent compliance of individual case safety reports (ICSRs) and, the performance and results of the Individual Case Medical Review (ICMR) personnel globally. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization. The focus of this role is strategic and operational with a broad scope and impact that includes ICMR oversight with regards to the performance and results of the ICMR personnel, as well as people management. This role has responsibilities for ensuring operational and scientific consistency, quality, development, and execution within the global ICMR organization, with a focus on the individual case medical safety review responsibilities. Key Responsibilities: Responsible for the supervision and performance management of one of the ICMR Therapeutic Area teams, specifically for business process execution of medical safety review activities, including timely completion, administrative issues management and oversight Provide leadership to the ICMR team by participating in the setting of vision, objectives, and goals for the ICMR personnel. Assume leadership role in ICMR, modeling responsibility, accountability, competency, initiative, and ethical behavior Responsible for the evaluation of quality, compliance, and performance metrics to optimize work processes and to ensure inspection readiness and compliance for staff. Responsible for metrics and work distribution In conjunction with the other ICMR managers, is responsible for ensuring the ICMR personnel perform as expected in their respective roles for all departmental activities. Responsible for the selection, training, supervision, development, and performance management of the specified ICMR Therapeutic Area team Responsible for the medical safety review of individual case safety reports Collaborate to provide input for the develop of SOPs, controlled documents, and continuous process improvements for the ICMR Organization, in partnership with cross functional areas, and in compliance with global and regional regulatory reporting requirements Participate as required as a member of the Risk Management Safety Team (RMST). May lead and/or participate in functional or cross functional projects as the ICMR subject matter expert Role may have several direct reports Energize, motivate, and establish a high performing team to aspire to excellence Cultivate a strong partnership with key stakeholders, including Global Pharmacovigilance Case Management (GPVCM), Global Clinical Development, and Global Regulatory Affairs. Partners with cross functional Global Clinical Safety & Pharmacovigilance (GCS&PV) Organizations including Clinical Safety Risk Management, Global PV Operations including Business Development Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements. Build strong working relationships across the organization.
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