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Safety Physician

Fortrea
Fortrea
1-2 years
Not Disclosed
Mumbai, Pune, India
10 March 10, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Physician
Company: Fortrea
Location: Multiple Locations (India)
Department: Clinical Safety / Pharmacovigilance
Job Type: Full-Time
Job ID: 26416
Experience Required: 1–2 Years of Pharmaceutical Industry or Clinical Practice Experience (Pharmacovigilance or Clinical Research preferred)

About Fortrea
Fortrea is a leading global contract research organization (CRO) providing end-to-end clinical development and pharmacovigilance solutions for pharmaceutical, biotechnology, and medical device companies. The organization supports sponsors across the product lifecycle by delivering high-quality safety monitoring, regulatory compliance, and clinical research services worldwide.

Role Overview
The Safety Physician is responsible for providing medical safety expertise for pharmaceutical products, medical devices, and combination products during the post-marketing phase. This role involves performing medical review of adverse event cases, evaluating safety data, and supporting pharmacovigilance activities to ensure patient safety and regulatory compliance.

The position requires strong clinical and medical knowledge to assess adverse events, determine causality, evaluate case seriousness, and support pharmacovigilance teams with medical guidance throughout case processing and safety review activities.

Key Responsibilities

Medical Case Review and Safety Assessment

  • Perform primary medical review of adverse event and safety cases.

  • Evaluate cases for seriousness, causality, labeling/listedness, and clinical relevance.

  • Review adverse event coding and patient narratives to ensure clinical accuracy and regulatory compliance.

Case Data Management and Documentation

  • Maintain and update case information in safety tracking systems and workflow tools.

  • Document medical assessments, case reviews, and feedback in relevant pharmacovigilance systems to support workflow tracking and reporting.

Quality Assurance and Medical Oversight

  • Conduct secondary medical review and quality control (QC) of safety cases when required.

  • Participate in retrospective quality reviews to identify trends, potential errors, and areas for process improvement.

  • Support quality assurance activities by ensuring pharmacovigilance processes meet regulatory and organizational standards.

Pharmacovigilance and Signal Detection

  • Participate in aggregate medical reviews of safety data.

  • Contribute to signal detection, signal evaluation, and safety analysis activities.

  • Support safety monitoring activities related to marketed pharmaceutical products and medical devices.

Training and Team Support

  • Provide medical guidance and training to pharmacovigilance case processing teams.

  • Support team members with clinical interpretation of adverse events and safety data.

Process Improvement and Client Collaboration

  • Contribute to continuous improvement initiatives related to pharmacovigilance processes and safety reporting.

  • Support strong working relationships with internal stakeholders and external clients to ensure high-quality service delivery.

Educational Qualifications

  • Bachelor’s degree in Medical Sciences, MD, DO, or an equivalent medical qualification.

  • Equivalent relevant experience may be considered in place of formal educational requirements.

Experience Requirements

  • 1–2 years of experience in the pharmaceutical industry, preferably in pharmacovigilance or clinical research.

  • 1–2 years of clinical practice experience is preferred.

Required Skills and Competencies

  • Strong understanding of medical sciences, disease diagnosis, and therapeutic treatments.

  • Knowledge of pharmacovigilance processes and adverse event evaluation.

  • Understanding of clinical research regulations and ICH-GCP guidelines.

  • Strong analytical and clinical assessment skills.

  • Excellent written and verbal communication abilities.

Language Requirements

  • English speaking proficiency at ILR Level 3 or higher.

  • English reading and writing proficiency at ILR Level 4 or higher.

Preferred Skills

  • Understanding of global pharmacovigilance regulatory requirements.

  • Experience with adverse event case processing and medical review activities.

Work Environment
The role may be performed in an office-based or home-based environment depending on project requirements and organizational policies.

Job Location
Multiple locations in India.