21 Sep
Fortrea
Maharashtra
Job Overview Provide medical safety expertise directly and indirectly to Sponsors of drugs devices and combination products in the post marketing period Summary of Responsibilities Undertake primary medical review of cases including medical assessment of the case for seriousness listedness labeling causality adverse event coding and narrative review Update and document daily case data case-feedback in appropriate trackers tools to facilitate tracking and workflow management Assume complete responsibility for all assigned deliverables in line with expected quality compliance and productivity SLAs and KPIs Provide training and guidance to the case processing team on medical aspects of case processing only after a tenure of 1 year Performs aggregate and signal analysis activities as required in support of single case processing Creates maintains and assumes accountability for a culture of high customer service Qualifications Minimum Required Bachelor s degree in medical science or MD or DO or equivalent degree Fortrea may consider relevant and equivalent experience in lieu of educational requirements Language Skills Speaking English at ILR level 3 or higher Writing Reading English at ILR level 4 or higher Experience Minimum Required Working knowledge of medical sciences diagnosis and therapeutics including drug treatments and procedures Knowledge and understanding of regulatory requirements for Clinical Research Knowledge and understanding of ICH-GCP guidelines Preferred Qualifications Include 1 to 2 years of Clinical practice experience Physical Demands Work Environment Office or home-based environment as requested by the line manager Learn more about our EEO Accommodations request here
📌 Medical Physician Specialist I
🏢 Fortrea
📍 Maharashtra
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