Fortrea
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
MD/DO – Associate Medical Manager, PSS/PV
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Fortrea
10,000+ employees
🏥 Healthcare
🧬 Biotechnology
💊 Pharmaceuticals
Healthcare • Biotechnology • Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
📋 Description
• Provide medical safety expertise, directly and indirectly, 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 • Perform 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 • MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 4 years of experience with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management • Strong understanding of regulatory requirements relating to Pharmacovigilance • At least 4 years pharmaceutical industry experience, including and specific to pharmacovigilance (post approval experience, case processing, medical review) and/or clinical research • 1 to 2 years of clinical practice experience
🏖️ Benefits
• Medical • Dental • Vision • Life • STD/LTD • 401(K) • ESPP • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable
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