Medical Reviewer | MBBS | Pharmacovigilance | Drug Safety | Mumbai / Bangalore

Job Title : Medical Reviewer | MBBS | Pharmacovigilance | Drug Safety | Mumbai / Bangalore

Job Description

We are hiring an experienced Medical Reviewer to support pharmacovigilance and drug safety operations. The role involves medical review of adverse-event cases, causality and seriousness assessment, medical coding review, case narratives, and medically relevant follow-up activities.

The ideal candidate must be an MBBS doctor with at least 2 years of clinical and/or Pharmacovigilance experience, with strong medical knowledge and an understanding of drug safety and regulatory processes.

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

• Provide medical guidance to Drug Safety teams.

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

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

• Provide medical advice for cases involving SUSARs.

• Participate in internal/client safety meetings and audits.

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

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

Required Skills

• MBBS / Medical Knowledge

• Pharmacovigilance / Drug Safety

• Adverse Event / Case Review

• Causality & Seriousness Assessment

• Medical Coding & ICSR Review

• SUSAR Knowledge

• Regulatory Compliance

• Medical Decision-Making

• Excellent Written & Verbal Communication

• MS Office

Qualifications

• MBBS or equivalent – Mandatory

• Minimum 2 years of clinical and/or Pharmacovigilance experience

• Strong understanding of Pharmacovigilance and drug safety processes.

• Good knowledge of medical terminology and regulatory requirements.

• Strong analytical, problem-solving, and decision-making skills.

Important Notes

• Location: Mumbai / Bangalore

• Work Mode: Work From Office

• Shift: General Shift

• Qualification: MBBS or Equivalent

• Mandatory: MBBS doctor with 2+ years clinical and/or Pharmacovigilance experience.

• Ex TCS Employees can't apply
  

• PAN and DOB are required for profile creation