Job Summary
Fortrea, a renowned global Contract Research Organization (CRO), is hiring a Medical Physician Specialist I to provide expert medical safety oversight in post-marketing pharmacovigilance for drugs, devices, and combination products. This role is ideal for candidates with a background in clinical medicine and a strong understanding of regulatory guidelines such as ICH-GCP. You will handle medical review of adverse events, case assessments, and support the case processing team while ensuring compliance with regulatory standards and client expectations.
Key Responsibilities
Perform primary medical review and medical assessment of individual case safety reports (ICSRs), including seriousness, causality, labeling, and coding.
Review and update case data and trackers/tools daily to ensure accurate workflow management.
Take full responsibility for all assigned deliverables ensuring adherence to quality, productivity, and compliance KPIs and SLAs.
Provide medical training and guidance to case processing teams (after completing one year in the role).
Engage in aggregate data evaluation and signal detection activities as required.
Maintain a strong focus on client satisfaction and high-quality service delivery in all activities.
Required Skills & Qualifications
Bachelor’s degree in Medical Science, MD, DO, or equivalent medical qualification.
Proficiency in clinical diagnosis, therapeutic procedures, and drug treatments.
Good understanding of global regulatory requirements in clinical research.
Knowledge of ICH-GCP guidelines.
English proficiency (ILR Level 3+ speaking, Level 4+ reading/writing).
Preferred Skills & Qualifications
Minimum 2 years of clinical practice experience preferred.
Perks & Benefits
Flexible work mode – Office or Home-based as per project requirements.
Exposure to cutting-edge global clinical research projects.
Opportunities for professional growth within a globally recognized CRO.
Involvement in multi-therapeutic clinical safety programs.
Company Description
Fortrea is a top-tier global CRO providing comprehensive clinical development and technological solutions to pharmaceutical, biotechnology, and medical device industries across 20+ therapeutic areas. Operating in over 100 countries, Fortrea transforms drug and device development processes with a strong focus on scientific rigor and regulatory excellence.
Work Mode
Hybrid (Office or Home-based as directed by the Line Manager)
Call-to-Action
Shape the future of drug safety and clinical development with Fortrea. Apply now for the position of Medical Physician Specialist I and contribute to global healthcare innovation.
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