Fortrea
Fortrea is a clinical research organization (CRO) with over 30 years of experience dedicated to accelerating the development of life-changing treatments by providing comprehensive clinical solutions for biopharma and MedTech companies. They offer a range of services including clinical trial management, pharmacology services, and regulatory strategy, all designed around the needs of their clients. Fortrea's mission is to put patients at the center of their work, aiming to bring innovative therapies to market faster through tailored, data-driven approaches.
clinical research • clinical trials
10,000+ employees
💊 Pharmaceuticals
Associate Medical Manager - Pharmacovigilance (PV)
April 4
Fortrea
Fortrea is a clinical research organization (CRO) with over 30 years of experience dedicated to accelerating the development of life-changing treatments by providing comprehensive clinical solutions for biopharma and MedTech companies. They offer a range of services including clinical trial management, pharmacology services, and regulatory strategy, all designed around the needs of their clients. Fortrea's mission is to put patients at the center of their work, aiming to bring innovative therapies to market faster through tailored, data-driven approaches.
clinical research • clinical trials
10,000+ employees
💊 Pharmaceuticals
📋 Description
• Provide medical safety expertise to sponsor drugs, devices, and combination products in the post marketing world • Undertake primary medical review of cases, including medical assessment of the case for seriousness, listed/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 • 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 • Undertake any other duties as required
🎯 Requirements
• MD or DO with at least 4 years of pharmacovigilance experience (clinical trial and post approval experience) • Comprehensive understanding of US healthcare system • Language skills: English proficient in speaking, writing, and reading • 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
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