01 Nov
|
Gratitude
|
Bengaluru
01 Nov
Gratitude
Bengaluru
# 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.
## Significant 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.
📌 424910 Medical Reviewer (Bengaluru)
🏢 Gratitude
📍 Bengaluru