Job Title : Medical Reviewer

Job Description:
The Medical Reviewer will be responsible for the medical review and assessment of adverse-event cases across clinical, solicited, spontaneous, and literature sources. The role involves evaluating case seriousness, causality, medical coding, narratives, adverse-event terms, suspect and concomitant medications, laboratory results, and medical history. The Medical Reviewer will provide medical guidance to Drug Safety teams, support high-quality adverse-event processing, handle medically relevant queries and follow-ups, and provide medical advice for cases involving suspected unexpected serious adverse reactions (SUSARs). The role also requires participation in internal/client safety meetings and audits while ensuring compliance with regulatory timelines, SOPs, and client procedures.

Key Responsibilities:

• Medically review clinical, solicited, spontaneous, and literature adverse-event cases.

• Perform medical assessment, including labeling and causality assessment.

• Review case seriousness, medical coding, and overall medical consistency.

• Review narratives, AE/SAE terms, suspect drugs, concomitant medications, laboratory results, and medical history.

• Maintain knowledge of relevant diseases and safety concerns related to marketed and developmental drugs.

• Support Drug Safety teams with medical guidance and ensure quality adverse-event processing.

• Review and respond to queries or comments related to Individual Case Safety Reports (ICSRs).

• Generate, send, and track medically relevant follow-up queries.

• Provide medical advice for cases involving SUSARs.

• Represent the Safety Physician team during internal/client safety meetings and audits.

• Ensure compliance with regulatory timelines, SOPs, and TCS/client procedures.

Mandatory Profile:

• MBBS doctor with a minimum of 2 years of clinical and/or Pharmacovigilance experience.

• Strong medical knowledge with the ability to apply it to drug safety.

• Understanding of Pharmacovigilance, drug safety, and regulatory processes.

• Strong problem-solving and medical decision-making skills.

• Excellent written and verbal communication.

• Ability to prioritize work and collaborate within a multidisciplinary team.

• MS Office/computer proficiency.

Important Eligibility:

• Ex-TCS employees are not eligible to apply.

• PAN and DOB are required for profile creation.