Job Summary
Fortrea, a leading global Contract Research Organization (CRO), is hiring a Medical Physician Specialist I to provide medical safety expertise on post-marketing drug, device, and combination product cases. This role involves primary medical review of safety cases, causality assessment, narrative development, and coding of adverse events, while ensuring full compliance with global regulatory standards. The ideal candidate will have a medical degree (MD, DO, or equivalent) and prior clinical practice or pharmacovigilance experience.
Key Responsibilities
Conduct primary medical review of individual case safety reports (ICSRs), assessing seriousness, labeling/listedness, causality, adverse event coding, and narratives.
Update and maintain daily tracking of cases and feedback using internal tools.
Ensure complete ownership of deliverables while meeting quality, productivity, and compliance KPIs and SLAs.
Provide training and guidance to the case processing team on medical aspects after one year in the role.
Perform aggregate data review and signal detection activities as required.
Foster and maintain a high standard of customer service excellence across all tasks.
Required Skills & Qualifications
Medical Degree (MBBS, MD, DO, or equivalent).
1–2 years of clinical practice or equivalent healthcare experience preferred.
Familiarity with medical sciences, diagnostics, therapeutics, and clinical procedures.
Knowledge of regulatory requirements for clinical research and post-marketing surveillance.
Understanding of ICH-GCP guidelines and clinical trial processes.
Strong English communication skills (ILR Level 3+ speaking, ILR Level 4+ reading/writing).
Perks & Benefits
Opportunity to work on global pharmacovigilance and post-marketing projects.
Hybrid work model (office or home-based based on manager discretion).
Exposure to various drug, device, and combination product safety cases.
Professional development and cross-functional training opportunities.
Part of a globally recognized CRO impacting over 20 therapeutic areas.
Company Description
Fortrea is a top-tier global Contract Research Organization (CRO) providing clinical development, drug safety, and technology solutions to pharmaceutical, biotechnology, and medical device companies. Operating in over 100 countries, Fortrea accelerates drug and device development across diverse therapeutic areas, ensuring patient safety and regulatory compliance.
Work Mode
Hybrid (Office or Home-based as per management discretion)
Call-to-Action
Take the next step in your clinical career! Apply now to join Fortrea as a Medical Physician Specialist I and make a difference in post-marketing drug safety.
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Brazil | Sao paulo |Attica :
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