Medical Safety Physician – Post Marketing Pharmacovigilance
Location: India (Office-Based or Remote/Home-Based as per business requirement)
Employment Type: Full-Time
Industry: Pharmacovigilance / Drug Safety / Clinical Research
Experience Required: 1–3 Years
About the Company
Fortrea is a global contract research organization delivering clinical development and post-marketing safety solutions to pharmaceutical, biotechnology, and medical device companies. The organization supports comprehensive pharmacovigilance operations aligned with international regulatory standards.
Role Overview
The Medical Safety Physician will provide medical safety expertise for post-marketing drugs, devices, and combination products. The role involves medical review of Individual Case Safety Reports (ICSRs), causality assessment, signal detection support, and regulatory-compliant safety documentation.
This position is suitable for medical professionals seeking career advancement in global drug safety and pharmacovigilance.
Educational Qualification
Bachelor’s degree in Medical Sciences, OR
MD / DO or equivalent medical qualification
Relevant equivalent experience may be considered
Experience Required
1–2 years of clinical practice experience preferred
Experience or exposure to pharmacovigilance or clinical research desirable
Working knowledge of diagnosis, therapeutics, and drug treatments
Understanding of ICH-GCP guidelines and regulatory safety frameworks
Language Requirements
English Speaking: ILR Level 3+ or higher
English Reading/Writing: ILR Level 4+ or higher
Key Responsibilities
Medical Case Review & Safety Assessment
Perform primary medical review of adverse event cases
Assess seriousness, listedness/labeling, and causality
Conduct adverse event coding and narrative review
Ensure regulatory-compliant documentation
Workflow & Compliance Management
Update and track case data in designated safety systems
Ensure adherence to SLAs, KPIs, and quality benchmarks
Maintain high documentation standards and audit readiness
Aggregate Reporting & Signal Analysis
Support aggregate safety reporting activities
Contribute to signal detection and benefit-risk evaluation
Assist in preparation of safety summaries and analyses
Training & Team Support
Provide medical guidance to case processing teams after one year of tenure
Promote a culture of compliance, quality, and customer focus
Core Competencies
Strong clinical and therapeutic knowledge
Understanding of pharmacovigilance regulations
Analytical and risk assessment capabilities
Attention to detail and documentation accuracy
Ability to work independently in office or remote settings
Why Apply?
This role provides exposure to global post-marketing pharmacovigilance operations, enabling medical professionals to build expertise in safety assessment, regulatory compliance, and drug risk management.
SEO Keywords:
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Explore more pharmacovigilance and clinical research opportunities at ThePharmaDaily.com.
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Warsaw |