Medical Physician Specialist I

Why This Role Matters
Medical safety professionals play a crucial role in ensuring that medicines, medical devices, and combination products remain safe for patients even after they reach the market. Their work involves monitoring adverse events, reviewing safety data, and ensuring compliance with global pharmacovigilance standards. This role helps pharmaceutical companies maintain patient safety and regulatory compliance while improving the overall quality of healthcare products.

Job Description
Fortrea is seeking a Medical Physician Specialist I to join its clinical safety team in Mumbai. This role focuses on providing medical safety expertise for drugs, devices, and combination products in the post-marketing phase. The position involves reviewing adverse event cases, assessing medical information, ensuring accurate safety documentation, and supporting pharmacovigilance activities in accordance with regulatory guidelines.

Key Features of the Role
• Position: Medical Physician Specialist I
• Company: Fortrea
• Location: Mumbai
• Category: Clinical / Pharmacovigilance
• Employment Type: Full-Time
• Work Environment: Office-based or home-based (as assigned)
• Experience Level: Early to Mid-Level Medical Professional

Responsibilities
• Perform primary medical review of adverse event cases and clinical safety data
• Assess case seriousness, causality, labeling status, and adverse event coding
• Review case narratives and ensure accurate safety documentation
• Maintain and update case data in internal trackers and workflow management tools
• Ensure all assigned deliverables meet quality, compliance, and productivity standards
• Support aggregate safety review and signal detection activities
• Provide guidance to the case processing team on medical aspects after gaining sufficient experience
• Contribute to maintaining high standards of customer service and regulatory compliance

Required Qualification
• Bachelor’s degree in medical science, MD, DO, or an equivalent medical qualification
• Equivalent relevant experience may be considered in place of formal educational requirements

Important Requirements
• Strong understanding of medical sciences, diagnosis, and drug therapies
• Knowledge of pharmacovigilance principles and clinical research regulations
• Familiarity with ICH-GCP guidelines and regulatory standards
• Strong written and spoken English communication skills
• Ability to analyze clinical safety data and maintain accurate documentation

Employment Options
• Office-based or remote work option depending on manager approval

What We Offer
• Opportunity to work in global pharmacovigilance and drug safety
• Exposure to international clinical research and regulatory standards
• Professional growth in clinical safety and drug monitoring
• Collaborative environment with medical, regulatory, and research professionals

Experience and Skills
• Clinical safety case review and pharmacovigilance knowledge
• Medical assessment of adverse events and causality
• Regulatory compliance and clinical research understanding
• Analytical thinking and attention to detail
• Effective communication with cross-functional teams

Salary Insights
• Salary not specified in the job listing
• Compensation is typically competitive for pharmacovigilance roles in global clinical research organizations and depends on experience and qualifications

Company Overview
Fortrea is a global contract research organization specializing in clinical development, patient safety, and regulatory services for pharmaceutical and biotechnology companies. The company supports drug development and post-marketing safety monitoring through advanced clinical research solutions and medical expertise.

FAQs

1. What is the main focus of this role?
   The role focuses on pharmacovigilance and medical safety review for drugs, devices, and combination products.

2. What qualifications are required?
   Candidates should have a medical degree such as a bachelor’s in medical science, MD, DO, or an equivalent qualification.

3. Is clinical experience required?
   Clinical practice experience of 1–2 years is preferred but may not always be mandatory.

4. Does the role involve patient treatment?
   No, this is a non-clinical role focused on drug safety and medical data analysis.

Application Tips
• Highlight experience in pharmacovigilance, drug safety, or clinical research if applicable
• Mention knowledge of ICH-GCP guidelines and regulatory standards
• Demonstrate strong analytical and documentation skills
• Emphasize clinical understanding of drug therapies and medical terminology