Medical Reviewer

Medical Reviewer

Domain: Life Sciences
Location: Mumbai / Bangalore
Work Mode: Work from Office
Shift: General Shift

Job Description

We are looking for an experienced Medical Reviewer with a strong medical background and knowledge of Pharmacovigilance and Drug Safety processes. The candidate will be responsible for medically reviewing adverse-event cases, performing medical assessments, and ensuring compliance with regulatory requirements and quality standards.

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.

• Provide medical guidance to Drug Safety teams to ensure high-quality adverse-event processing.

• 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 suspected unexpected serious adverse reactions (SUSARs).

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

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

Required Skills

• Strong Medical Knowledge

• Pharmacovigilance

• Drug Safety

• Medical Review

• Causality Assessment

• Adverse Event Assessment

• Medical Coding

• Regulatory Compliance

• ICSR Review

• MS Office

Eligibility

• Qualification: MBBS or equivalent

• Experience: Minimum 2 years of clinical and/or Pharmacovigilance experience.

• Strong medical knowledge with the ability to apply clinical expertise to Drug Safety activities.

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

• Excellent written and verbal communication skills.

• Ability to prioritize tasks and work effectively in a multidisciplinary team.

Important Note

• Ex-TCS employees are not eligible to apply.

• PAN and Date of Birth (DOB) are mandatory for profile creation.