Medical Safety Reviewer (Bogotá)

Responsibilities

• Provide in‑line medical review of individual case safety reports, clinical trials, and other sources. Determine or confirm the need for expedited reporting to regulatory agencies, ensure quality, coherence, and accuracy of the case narrative, perform a medical assessment in the context of available safety data and the known safety profile, and provide a company statement with a causality assessment to be included in the Individual Case Report.
• Improve the accuracy and completeness of the case report by generating medical queries, as needed, and communicating them to the corresponding site via the safety database.
• Ensure compliance with global expedited reporting timelines with timely case assessment.
• Under the direction of the MSR Director, perform Analysis of Similar Events (AOSE) when applicable.
• May participate in quality review of Individual Case Safety Reports (ICSRs) from other MSR Physicians and Associates....