Medical Reviewer - Pharmacovigilance / Drug Safety

Why This Role Matters

Medical reviewers play a vital role in ensuring the safety of pharmaceutical products throughout their lifecycle. They analyze adverse event reports, review clinical safety data, and ensure that potential risks associated with medications are properly evaluated and documented. The Medical Reviewer – Pharmacovigilance role focuses on reviewing clinical and post-marketing safety cases to identify potential safety signals and ensure accurate medical evaluation of adverse events. This helps pharmaceutical companies maintain high safety standards and protect patient health. Another key aspect of the role is ensuring compliance with global pharmacovigilance regulations and safety reporting standards. Medical reviewers evaluate case narratives, assess causality, and verify the medical accuracy of safety data before submission to regulatory authorities. In addition, they collaborate with drug safety teams, clinical research professionals, and regulatory experts to improve the quality of safety reporting and maintain compliance with international guidelines. Overall, this role combines clinical expertise, drug safety knowledge, and regulatory compliance to support safe pharmaceutical development and monitoring.

Job Description

The Medical Reviewer – Pharmacovigilance is responsible for performing medical reviews of adverse event cases from clinical trials, post-marketing surveillance, and literature sources. Professionals in this role assess the medical accuracy of case reports, review clinical narratives, evaluate seriousness criteria, and ensure correct medical coding and classification of adverse events. The role also involves evaluating suspect drugs, concomitant medications, laboratory findings, and patient medical histories to determine potential drug-related safety risks. Additionally, medical reviewers provide medical guidance to pharmacovigilance teams, assist with safety queries, and contribute to regulatory compliance by following global safety reporting timelines and procedures. They also participate in safety discussions, audits, and internal forums to ensure high-quality drug safety monitoring and reporting.

Key Features of the Role:

• Opportunity to work in pharmacovigilance and drug safety operations.
• Involvement in clinical safety case review and medical assessment.
• Collaboration with drug safety, regulatory, and clinical research teams.
• Exposure to global safety databases and pharmacovigilance systems.
• Opportunity to support regulatory compliance and patient safety monitoring.
• Role within the business process services division of Tata Consultancy Services.

Responsibilities

• Perform medical review of clinical, spontaneous, and solicited safety cases.
• Conduct medical assessments including labeling review and causality evaluation.
• Review adverse event seriousness, medical coding, and case narratives.
• Evaluate suspect drugs, concomitant medications, laboratory results, and medical history.
• Support drug safety teams with medical expertise and safety awareness.
• Respond to queries related to individual case safety reports in safety databases.
• Generate and track follow-up queries for additional safety information.
• Provide medical input on cases involving Suspected Unexpected Serious Adverse Reactions (SUSAR).
• Ensure compliance with global and local pharmacovigilance procedures and regulatory timelines.
• Participate in internal safety meetings, audits, and client discussions.

Required Qualifications

• Strong medical knowledge relevant to pharmacovigilance and drug safety.
• Good understanding of adverse event reporting and regulatory processes.
• Strong analytical and problem-solving skills.
• Excellent interpersonal and communication abilities.
• Ability to work in multidisciplinary teams.

Educational Requirements

• MBBS or equivalent medical qualification.
• MD or higher medical qualification is preferred.

Experience and Skills

• 9 months to 4 years of experience in pharmacovigilance or clinical research.
• Experience in drug safety case processing or medical review preferred.
• Good understanding of pharmacovigilance regulations and safety reporting.
• Proficiency in MS Office and safety database systems.
• Ability to analyze clinical data and medical case narratives.

Salary Insights

Medical reviewers in India typically earn ₹6 LPA – ₹15 LPA, depending on experience, expertise in pharmacovigilance, and organizational role.

Company Overview

Tata Consultancy Services (TCS) is one of the largest IT services and consulting companies globally. The organization provides technology-driven services across multiple sectors, including healthcare, life sciences, and pharmacovigilance. Through its Business Process Services division, TCS supports pharmaceutical companies with drug safety operations, regulatory services, and clinical data management.

FAQs

• Who can apply for this role?
Candidates with an MBBS or equivalent medical qualification and experience in pharmacovigilance or clinical research.

• Is pharmacovigilance experience mandatory?
It is preferred but not always mandatory if the candidate has strong medical knowledge.

• What type of work environment is involved?
The role involves working with drug safety teams and regulatory professionals in a corporate healthcare services environment.

• What is the job location?
The position is based in Mumbai.

Application Tips

• Highlight your pharmacovigilance or clinical research experience in your resume.
• Clearly mention drug safety tools or safety database systems you have used.
• Emphasize knowledge of adverse event reporting and causality assessment.
• Include experience related to clinical case review or medical evaluation.
• Ensure your resume highlights strong medical knowledge and analytical skills.