Job Title: Medical Physician Specialist I – Pharmacovigilance & Drug Safety
Location: Pune, Maharashtra, India
Job Category: Clinical / Medical Safety
Job ID: 26373
Company: Fortrea
Job Overview
Fortrea is seeking a Medical Physician Specialist I to provide medical safety expertise for drugs, medical devices, and combination products in the post-marketing phase. This role supports global pharmacovigilance operations by conducting medical review of Individual Case Safety Reports (ICSRs), ensuring regulatory compliance, and contributing to aggregate safety and signal detection activities.
This opportunity is well-suited for medical professionals with strong knowledge of clinical practice, drug safety regulations, and ICH-GCP guidelines who are looking to build or advance a career in pharmacovigilance and medical review within a global CRO environment.
Key Responsibilities
Perform primary medical review of safety cases, including assessment of seriousness, causality, listedness, labeling, adverse event coding, and narrative review
Ensure accurate documentation and daily case updates in tracking systems to maintain workflow transparency
Take full accountability for assigned deliverables in line with quality standards, compliance requirements, SLAs, and KPIs
Support aggregate safety reporting and signal detection activities as required
Provide medical guidance and training to case processing teams after completion of one year in role
Maintain high standards of customer service and sponsor engagement
Ensure alignment with global pharmacovigilance regulations and company SOPs
Educational Qualification
Bachelor’s degree in Medical Sciences, MD, DO, or equivalent medical qualification
Equivalent relevant experience may be considered
Experience Required
1–2 years of clinical practice experience preferred
Strong working knowledge of medical sciences, diagnosis, therapeutics, and drug treatments
Understanding of global regulatory requirements for Clinical Research
Knowledge of ICH-GCP guidelines and post-marketing safety reporting standards
Experience in pharmacovigilance or drug safety is advantageous
Language Proficiency
English Speaking: ILR Level 3+ or higher
English Reading/Writing: ILR Level 4+ or higher
Work Environment
Office-based or home-based work model, as determined by the line manager
Why Join Fortrea?
Fortrea is a leading global contract research organization delivering clinical development and post-marketing safety solutions to pharmaceutical and biotechnology sponsors. The organization emphasizes regulatory excellence, scientific integrity, and patient safety across all therapeutic areas.
This role offers:
Exposure to global pharmacovigilance operations
Career progression in medical safety and drug risk management
Involvement in signal detection and aggregate reporting
Collaborative environment with cross-functional clinical and safety teams
Fortrea is an Equal Opportunity Employer and is committed to providing inclusive workplace practices and reasonable accommodations where applicable.
This job posting is optimized for search visibility in Medical Safety Officer, Pharmacovigilance Physician, Drug Safety Specialist, Clinical Research Medical Review, and Post-Marketing Surveillance careers in India on ThePharmaDaily.com.
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