Medical Physician Specialist Ii (Maharashtra)

Medical Physician Specialist Ii (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 secondary medical review QC role and retrospective review of cases reviewed QA role as required for measuring quality of deliverables identifying error trends training needs and areas of improvement only after a tenure of greater than 1year Performs aggregate medical review and signal detection analysis activities as required Enhances existing client relationships whenever possible Creates maintains and assumes accountability for a culture of high customer service Participates in process improvement activities across Company 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 Good understanding of regulatory requirements relating to Pharmacovigilance Up to 1 year of pharmaceutical industry experience including pharmacovigilance case processing medical review and clinical research 1 to 2 years of Clinical practice experience Physical Demands Work Setting Office or home-based environment as requested by the line manager Learn more about our EEO Accommodations request here

📌 Medical Physician Specialist Ii
🏢 Fortrea
📍 Maharashtra

The original job offer can be found in Kit Job:
kitjob.in/job/178910321