Under the direction and oversight of the ICMR Leadership the ICMR Physician will: As required per SOP, provide in-line medical review of individual case safety reports (ICSRs) arising from our 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. Conduct Individual Case Reviews (ICRs) in the Integral Safety Database for both clinical trials and post-marketing environments, focusing on cases that meet the scope criteria to identify rare, severe, and potentially drug-related index cases that may prompt signal evaluation.



Perform Medical Devices and Combination Products Reportability Assessment to determine whether ICSR[s] meet the criteria for expediated reporting to heath authorities. May request additional information deemed important for medical review Ensure compliance with global expedited reporting timelines with timely case assessment Under the direction of the ICMR Director (TAL) and/or the Executive Director, perform Analysis of Similar Events (AOSE) when applicable May participate in quality review of ICSR[s] from other ICMR team members May lead and/or participate in cross-functional projects as the ICMR subject matter expert, contributing to continuous process improvement of ICSR assessments Consult with the Clinical director for the trial and with the Clinical Safety and Risk Management Physician, as needed, for cases requiring additional clinical or safety subject matter expertise May participate in the training of the specified ICMR Team May participate in process, quality, innovation, technology, and other business-related activities May p

📌 Associate Principal Scientist, Medical Safety Review Physician-5 (Bogotá)
🏢 Msd Malaysia
📍 Bogotá