Job Description

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 General 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 ICSRs 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 ICSRs 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 othe

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