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Experience- 5 to 10 Years Qualification- M.B.B.S. in Any Specialization / Medical-MS/MD in Any Specialization RESPONSIBILITIES Triage of adverse event reports in Argus Database Medical review of adverse event reports in Argus Database Causality assessment of adverse event reports in Argus Database Signal management activities Medical review of aggregate reports SmPC and PIL evaluation, comparison, and updates as required DESIRED SKILLS Expert knowledge of international guidelines and country specific regulatory requirements (FDA, ICH GCP, GVP Modules; respective EU Clinical Trial Directive etc.) Experience with ICSR review and assessment Solid interpersonal skills and the ability to be versatile in varying environments Valuable attention to detail and decision-making skills. .