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 strong 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, medical, or compliance issues appropriately.

3.



Team & People Management

- Lead, manage, mentor, and coach Medical Reviewers / Safety Physicians.
- Allocate workload based on case volumes, priorities, and business requirements.
- Monitor team productivity, quality, and turnaround-time metrics.
- Conduct resource planning and capacity forecasting.
- Identify resource gaps and operational risks and develop appropriate mitigation plans.
- Conduct performance reviews, coaching, mentoring, and career development activities.
- Support recruitment, onboarding, training, and competency development of Medical Review team members.

4. Quality Management

- Own and monitor quality and turnaround-time metrics for Medical Review deliverables.
- Identify trends, recurring issues, and opportunities for improvement.
- Lead or support Root Cause Analysis (RCA) for medical review defects.
- Develop and implement appropriate CAPA.
- Conduct reviewer calibration and quality reviews.
- Ensure audit and inspection readiness for Medical Review activities.
- Drive continuous improvement initiatives to improve quality, efficiency, and operational performance.

5. Client & Stakeholder Management

- Represent the Medical Review function in client governance meetings and operational reviews.
- Present quality trends, performance metrics, risks, and improvement initiatives to clients and senior stakeholders.
- Act as an escalation point for complex medical review and operational issues.
- Collaborate with Pharmacovigilance, Safety Operations, Quality, Training, and other cross-functional teams.
- Maintain effective communication with internal and external stakeholders.

Required Qualifications





- Graduate/Postgraduate/Doctorate degree in Medical Sciences or equivalent.
- MBBS / MD or equivalent medical qualification preferred.
- 5+ years of relevant experience in Medical Review / Pharmacovigilance / Drug Safety, with strong hands-on ICSR Medical Review experience.
- Proven experience in leading, managing, mentoring, or providing SME support to Medical Reviewers / Safety Physicians.
- Solid hands-on understanding of ICSR medical review.
- Hands-on experience with Veeva Safety and/or Argus Safety.
- Strong knowledge of causality, seriousness, listedness, and labeling assessment.
- Experience in post-lock medical review and medical quality review.
- Experience with RCA/CAPA and process improvement.
- Strong written and verbal English communication skills.

Preferred Skills

- Medical Review Management
- ICSR Medical Review
- Pharmacovigilance / Drug Safety
- Medical Review SME
- Safety Physician Leadership
- Veeva Safety
- Argus Safety
- Causality Assessment
- Seriousness Assessment
- Listedness Assessment
- Labeling Assessment
- Post-Lock Medical Review
- Medical Quality Review / Quality Management
- RCA / CAPA
- Quality & TAT Management
- Resource Planning
- Capacity Forecasting
- Performance Management
- Team Leadership & Mentoring
- Client / Stakeholder Management
- SOP and Regulatory Compliance
- Process Improvement and Standardization

Ideal Candidate Profile

Candidates currently working as:

- Medical Review Manager
- Medical Review Team Manager
- Medical Review Lead
- Medical Review SME
- Medical Review Specialist
- Safety Physician Lead
- Pharmacovigilance Medical Lead
- Drug Safety Medical Lead
- Senior Medical Reviewer
- Safety Physician

Candidates should demonstrate a combination of hands-on ICSR medical review expertise and leadership/SME capabilities. Candidates with significant experience in team management, quality management, client interaction, resource planning, and operational leadership will be preferred.

📌 Medical Review Manager / SME / Team Lead (Hyderabad)
🏢 Clinovo
📍 Hyderabad