Under the direction and oversight of the Associate Vice-President, Head of ICMR, ICMR Senior Director, ICMR Directors/Therapeutic Area Team Leads (TAL), the Medical Safety Review (MSR) Physician will: As required per SOP, provide in-line medical review of individual case safety reports (ICSRs), LLC (Company) clinical trials and other sources, as required, and will include the following actions: Determine or confirm the need for expedited reporting to regulatory agencies, ensure the quality coherence, and accuracy of the case narrative, performs a medical assessment of the case in the context of the available safety data and the known safety profile, and provide a company statement and a causality assessment which will be included as part of the Individual Case Report. The MSR Physician will work closely and collaboratively with colleagues in other departments in the Company, including but not limited to: Clinical Safety Scientists, Clinical Directors in Clinical Research, CSRM Physicians, and CSRM Associates and Scientists, Global and US Pharmacovigilance and Global Pharmacovigilance Case Management. The MSR Physician will be an extended member of the Risk Management Safety Teams (RMST’s) for the products that they support, and other relevant sub-teams. Education Requirement: M.D. or equivalent Ex US degree in Medicine **Required Skills**: - Minimum of 1 year experience in clinical medicine following training, with 3 years of experience preferred; this experience is required in patient care settings - A minimum of 3 years of relevant work experience that may include both clinical medicine practice post training and pharmaceutical industry experience required - Excellent writing and communication skills in English required - Effective presentation skills and experience influencing and negotiating required - Computer skill required - Problem-solving, conflict resolution, and critical thinking skills are required **Preferred Experience and Skills**: - Medical specialization - Experience in drug safety, pharmacovigilance and/or risk management is highly desirable - Prior medical review and/or case management experience - Relevant Safety Systems Experience (i.e., Argus, ARIS-G, etc.) - Drug development experience (early or late phase clinical research, regulatory affairs, and/or safety/PV) - Demonstrated leadership skills in managing programs & processes, leading meetings, and influencing peers and direct reports to drive results - Experience working and collaborating with global teams **Search Firm Representatives Please Read Carefully** **Employee Status**: Regular **Relocation**: **VISA Sponsorship**: **Travel Requirements**: **Flexible Work Arrangements**: Hybrid **Shift**: **Valid Driving License**: **Hazardous Material(s)**: **Job Posting End Date**: 04/30/2025 **Requisition ID**:R347441