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
• Positive attention to detail and decision-making skills.
📌 Medical Reviewer Mumbai
🏢 Unichem Laboratories
📍 Mumbai
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