Medical Review Manager / SME / Team Lead

Job Description | Pharmacovigilance / Drug Safety

Job Summary

We are looking for an experienced Medical Review Manager / SME / Team Lead to lead, oversee, and provide subject matter expertise for Medical Review activities supporting Pharmacovigilance and Drug Safety operations.

The role will be responsible for ICSR medical review, medical quality, team leadership, resource planning, turnaround time, process compliance, stakeholder management, and continuous improvement.

The ideal candidate should have solid hands-on experience in ICSR medical review, along with proven experience in Medical Review SME/leadership, people management, quality management, and operational delivery.

Key Responsibilities

1. Medical Review & Clinical Oversight
- Lead and oversee Medical Review activities for Individual Case Safety Reports (ICSRs).
- Perform and/or provide oversight for medical review of safety cases in accordance with applicable SOPs, processes, and regulatory requirements.
- Review case narratives, medical history, concomitant medications,



laboratory data, and other clinical information.
- Provide medical assessment and guidance on causality, seriousness, listedness, and labeling.
- Conduct and oversee post-lock medical review and medical quality review.
- Identify and resolve medical inconsistencies, data discrepancies, and quality issues.
- Provide guidance to Medical Reviewers on complex or medically challenging cases.
- Ensure consistency and accuracy of medical review decisions across the team.

2. SME & Process Leadership
- Act as the Subject Matter Expert (SME) for Medical Review processes.
- Provide process and medical guidance to Medical Reviewers and Safety Physicians.
- Support reviewer calibration and establish consistent medical assessment practices.
- Develop and maintain standardized medical review practices.
- Support process improvement and standardization initiatives.
- Escalate critical safety, quality, med

📌 Medical Review Manager (Bengaluru)
🏢 Clinovo
📍 Bengaluru