01 Nov
|
Gratitude
|
Mumbai
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.
- Valuable 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
📌 Medical Reviewer | MBBS | Pharmacovigilance | Drug Safety | Mumbai / Bangalore
🏢 Gratitude
📍 Mumbai