Job DescriptionUnder 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 Global 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 reviewEnsure compliance with global expedited reporting timelines with timely case assessmentUnder the direction of the ICMR Director (TAL) and/or the Executive Director, perform Analysis of Similar Events (AOSE) when applicableMay participate in quality review of ICSRs from other ICMR team membersMay lead and/or participate in cross-functional projects as the ICMR subject matter expert,



contributing to continuous process improvement of ICSR assessmentsConsult 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 expertiseMay participate in the training of the specified ICMR TeamMay participate in process, quality, innovation, technology, and other business-related activitiesMay participate on special projects or rotational assignments within or outside of ICMR as part of their professional developmentThe ICMR 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 ICMR Physician will be a core member of the Risk Management Safety Teams (RMSTs) for the products they support, as well as other relevant sub-teams.Education RequirementM.D. (Degree in Medicine)Required SkillsMinimum of 1 year experience in clinical medicine following training,



with 3 years of experience preferred; this experience is required in patient care settingsA minimum of 3 years of relevant work experience that may include both clinical medicine practice post-training and pharmaceutical industry experience requiredThe candidate must have a strong understanding of scientific and medical conceptsExcellent writing and communication skills in English requiredEffective presentation skills and experience influencing and negotiating requiredComputer skill required- use of database and basic MS Office suite applicationsProblem-solving, conflict resolution, and critical thinking skills are requiredPreferred Experience and SkillsMedical specializationExperience in drug safety, pharmacovigilance and/or risk management is highly desirablePrior medical review and/or case management experienceRelevant 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 resultsExperience working and collaborating with general teamsRequired SkillsAdaptability, Audit Process Evaluations, Clinical Judgment, Compliance Program Development, Critical Thinking, Data Analysis, Decision Making, Detail-Oriented, Drug Safety Surveillance, Ethical Compliance, Medical Writing, Pharmacovigilance, Post Marketing Surveillance, Regulatory Communications, Regulatory Compliance AuditsEmployee StatusRegularRelocationNo relocationVISA SponsorshipNoTravel RequirementsNo Travel RequiredFlexible Work ArrangementsHybridShiftNot IndicatedValid Driving LicenseNoHazardous Material(s)n.AJob Posting End Date09/16/2026#J-18808-Ljbffr

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