424910 Medical Reviewer

# Job Description: Medical Reviewer – Pharmacovigilance

**Job Title:** Medical Reviewer\

**Job ID:** 424910\

**Domain:** Life Sciences / Pharmacovigilance\

**Locations:** Mumbai and Bangalore\

**Qualification:** MBBS or equivalent\

**Experience:** Minimum 2 years of clinical and/or Pharmacovigilance experience\

**Band:** BPO 3/4\

**Work Schedule:** General Shift\

**Work Mode:** Work from Office

## Job Summary

We are seeking qualified MBBS doctors with a minimum of 2 years of clinical and/or Pharmacovigilance experience for the role of Medical Reviewer. The candidate will be responsible for conducting medical reviews of adverse-event cases, performing causality and seriousness assessments, ensuring medical accuracy, and supporting drug safety operations in compliance with regulatory requirements and company procedures.

## Key Responsibilities

- Medically review clinical trial, solicited, spontaneous, and literature adverse-event reports.

- Perform medical assessments, including causality assessment, seriousness evaluation, and labeling assessment.

- Review case details for medical consistency, accuracy, and completeness.

- Evaluate adverse events (AEs), serious adverse events (SAEs), suspect drugs, concomitant medications, laboratory results, and patient medical history.

- Review medical narratives, medical coding, and safety case documentation.

- Maintain up-to-date knowledge of relevant diseases, drug safety concerns, and marketed and investigational medicinal products.

- Provide medical guidance and support to Drug Safety and Pharmacovigilance teams.

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

- Generate, issue, and track medically relevant follow-up queries to obtain additional case information.

- Provide medical advice for cases involving Suspected Unexpected Serious Adverse Reactions (SUSARs).

- Participate in internal and client safety meetings and audits as a representative of the Safety Physician team.

- Ensure compliance with regulatory reporting timelines, Standard Operating Procedures (SOPs), and TCS/client procedures.

- Maintain high standards of medical accuracy, documentation, and quality throughout the review process.

## Required Qualifications

- MBBS degree or equivalent medical qualification.

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

- Strong medical knowledge and the ability to apply clinical expertise to drug safety assessments.

- Understanding of Pharmacovigilance principles, drug safety processes, and regulatory requirements.

- Knowledge of adverse-event assessment, causality assessment, and seriousness evaluation.

## Required Skills

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

- Excellent written and verbal communication skills.

- Ability to review complex medical information and ensure accuracy.

- Strong attention to detail and documentation skills.

- Ability to prioritize tasks and meet regulatory deadlines.

- Proficiency in MS Office and general computer applications.

- Ability to work effectively in a multidisciplinary team environment.

## Work Conditions

- Work locations: Mumbai or Bangalore.

- General day shift.

- Work from office.

- Full-time position.

## Important Hiring Conditions

- Former TCS employees are not eligible for this position.

- PAN and Date of Birth (DOB) details are required for employee profile creation, subject to applicable data privacy and verification policies.

## Ideal Candidate Profile

The ideal candidate is an MBBS-qualified medical professional with at least 2 years of clinical and/or Pharmacovigilance experience, strong medical assessment capabilities, and an understanding of drug safety regulations. The candidate should be detail-oriented, medically proficient, and committed to maintaining the quality and compliance of adverse-event case reviews.