Medical Physician Specialist II

1 - 5 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As a Medical Safety Expert, your primary role will be to provide medical safety expertise to Sponsors of drugs, devices, and combination products during the post-marketing period. You will be responsible for undertaking the primary medical review of cases, updating and documenting case data, and assuming complete responsibility for assigned deliverables while maintaining quality, compliance, and productivity standards. Additionally, you will provide training and guidance to the case processing team on medical aspects of case processing. Key Responsibilities: - Undertake primary medical review of cases including assessment for seriousness, listedness/labeling, causality, adverse event coding, and narrative review. - Update and document daily case data in appropriate trackers/tools for tracking and workflow management. - Assume complete responsibility for assigned deliverables in line with quality, compliance, and productivity SLAs and KPIs. - Provide training and guidance to the case processing team on medical aspects of case processing after a tenure of 1 year. - Perform secondary medical review (QC role) and retrospective review of cases (QA role) for measuring quality, identifying error trends, and training needs. - Perform aggregate medical review and signal detection/analysis activities as required. - Enhance existing client relationships and maintain a culture of high customer service. - Participate in process improvement activities across the company. Qualifications Required: - Bachelor's degree in medical science or MD or DO or equivalent degree. - Relevant and equivalent experience may be considered in lieu of educational requirements. - Language Skills: Speaking English at ILR level 3+ or higher. Writing/Reading English at ILR level 4+ or higher. Additional Company Details: The work environment can be either office-based or home-based, as requested by the line manager.,

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Fortrea logo
Fortrea

Pharmaceuticals

Durham

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