Job title : Medical Reviewer

Job Description :

We are looking for a qualified medical professional to join the Life Sciences team as a Medical Reviewer. The role involves conducting medical reviews of adverse-event cases, performing causality and seriousness assessments, ensuring medical consistency, and supporting pharmacovigilance and drug safety operations in compliance with regulatory requirements and established procedures.

Experience : 2-7yrs

Location : Mumbai, Maharashtra / Bengaluru, Karnataka

Required Skills : 

1. MBBS or equivalent medical qualification

2. Pharmacovigilance and Drug Safety

3. Adverse Event (AE) and Serious Adverse Event (SAE) Assessment

4. Medical Review, Causality Assessment, and Medical Coding

5. Medical Documentation and Regulatory Compliance

Key Responsibilities :

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

• Perform medical assessments, including product-labeling and causality assessments.

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

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

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

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

• Review and respond to queries and comments 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 in internal and client meetings, safety discussions, and audits.

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

Qualifications : 

• MBBS or an equivalent medical qualification is mandatory.

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

• Strong medical knowledge and the ability to apply clinical judgment to drug safety cases.

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

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

• Excellent written and verbal communication skills.

• Ability to prioritize tasks and work effectively with multidisciplinary teams.

• Proficiency in MS Office and computer applications.​

Important Points : 

• Ex TCS Employees can't apply.

• PAN and DOB are required for profile creation.