Safety Physician | Pune / Mumbai | Remote Opportunity
Company: Fortrea
Location: Pune or Mumbai, India (Remote Eligible)
Employment Type: Full-Time
Job ID: 26416
Application Deadline: 05 March 2026
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing end-to-end clinical development, pharmacovigilance, and regulatory solutions to pharmaceutical, biotechnology, and medical device companies. With a strong focus on patient safety and regulatory compliance, Fortrea supports sponsors in ensuring safe and effective therapies across global markets.
Position Overview
The Safety Physician provides medical safety expertise for post-marketing pharmacovigilance activities related to drugs, medical devices, and combination products. This role involves primary and secondary medical review of individual case safety reports (ICSRs), aggregate safety analysis, signal detection, and regulatory compliance oversight.
The position plays a critical role in maintaining high-quality pharmacovigilance deliverables aligned with global regulatory requirements and sponsor expectations.
Key Responsibilities
Medical Case Review and Assessment
Perform primary medical review of safety cases.
Conduct medical assessment for seriousness, causality, and listedness/labeling.
Ensure accurate adverse event coding and narrative review.
Maintain updated documentation in tracking tools to support workflow management.
Quality Control and Compliance
Perform secondary medical review (Quality Control role) and retrospective quality review (Quality Assurance role).
Identify error trends, training gaps, and areas for process improvement.
Ensure deliverables meet quality, compliance, and productivity SLAs and KPIs.
Aggregate Safety and Signal Management
Conduct aggregate medical reviews and contribute to signal detection and analysis activities.
Support interpretation of safety data trends and risk evaluation processes.
Team Support and Training
Provide medical training and guidance to pharmacovigilance case processing teams.
Offer subject matter expertise on clinical and therapeutic aspects of adverse event evaluation.
Client and Process Excellence
Strengthen sponsor relationships through high-quality service delivery.
Contribute to process improvement initiatives across pharmacovigilance operations.
Promote a culture of accountability, compliance, and customer service excellence.
Educational Qualifications
Bachelor’s degree in Medical Sciences, MD, DO, or equivalent medical qualification.
Equivalent relevant experience may be considered in lieu of formal educational requirements.
Experience Required
1–3 years of relevant experience in pharmacovigilance, clinical research, or related medical safety roles.
Up to 2 years of pharmaceutical industry experience, including case processing and medical review, preferred.
1–2 years of clinical practice experience preferred.
Strong working knowledge of medical sciences, diagnosis, therapeutics, and drug treatments.
Understanding of global regulatory requirements in Clinical Research and Pharmacovigilance.
Working knowledge of ICH-GCP guidelines.
Preferred Qualifications
Strong understanding of global pharmacovigilance regulations and post-marketing safety requirements.
Experience in signal detection, aggregate safety review, or risk management activities.
Language Requirements
Speaking: English proficiency at ILR level 3 or higher.
Writing/Reading: English proficiency at ILR level 4 or higher.
Work Environment
Office-based in Pune or Mumbai, or remote/home-based as approved by the line manager.
Collaborative, compliance-driven pharmacovigilance environment.
Focused on regulatory excellence and patient safety.
Equal Opportunity Statement
Fortrea is committed to building a diverse and inclusive workforce. All qualified applicants will receive consideration in accordance with applicable employment laws and regulations.
Explore global Pharmacovigilance, Drug Safety, Clinical Research, and Medical Affairs careers at ThePharmaDaily.com.
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