Medical Reviewer Jobs at Alkem Laboratories—Apply Now
Medical Reviewer Jobs: The Medical Reviewer – Pharmacovigilance plays a pivotal role in ensuring the safety, accuracy, and scientific rigor of Alkem’s global drug safety operations. As part of the pharmacovigilance medical team, this role focuses on the medical assessment of safety reports, regulatory compliance, and high-quality documentation that strengthens patient safety and product reliability across international markets.
Medical Reviewer Jobs Details:
- Position: Medical Reviewer
- Location: Mumbai, Maharashtra
Medical Reviewer Jobs About the Company:
Alkem Laboratories Limited is a leading Indian multinational pharmaceutical company headquartered in Mumbai, recognized among India’s top five pharma organizations. With a strong global presence across 50+ countries, Alkem specializes in high-quality generic medicines, formulations, and nutraceuticals. Its portfolio includes some of India’s most trusted brands, such as Clavam, Pan, Pan-D, and Taxim-O, consistently ranked among the top 50 pharmaceutical brands nationwide. Driven by innovation, quality, and scientific excellence, Alkem continues to build a healthier future through accessible and reliable healthcare solutions.
Qualifications:
- MBBS (Mandatory)
Preferred Experience
- 2–4 years of experience in medical review of ICSRs
- Experience in global pharmacovigilance systems, safety databases, and regulatory practices is an added advantage.
Role:
The Medical Reviewer – Pharmacovigilance is responsible for the end-to-end medical evaluation of Individual Case Safety Reports (ICSRs) from global sources. The role ensures accurate causality assessment, compliance with regulatory standards, and high-quality safety documentation. It involves close collaboration with safety operations teams, literature surveillance, and regulatory functions to maintain robust pharmacovigilance practices.
Key Responsibilities
1. ICSR Medical Assessment
- Perform medical review of ICSRs from all data sources.
- Evaluate clinical details for completeness, consistency, and medical relevance.
2. Causality, Seriousness & Expectedness
- Determine the company’s causality assessment for each case.
- Assess the seriousness and expectedness in accordance with regulatory and company guidelines.
3. Expedited Case Review
- Prioritize and review expedited cases (e.g., SUSARs) for timely global reporting.
- Ensure regulatory timelines are consistently met.
4. Final Quality Check (PPQC)
- Conduct post-processing quality checks on finalized ICSRs.
- Verify the accuracy, integrity, and medical correctness of safety data.
5. Literature Review Support
- Perform PPQC for literature abstracts and ensure accurate medical data extraction.
- Validate identification and classification of safety signals from publications.
6. Safety Documentation
- Review and finalize medical summaries and case narratives.
- Ensure clarity, scientific accuracy, and compliance with global safety standards.
7. MICC Case Triage & Review
- Conduct safety assessments for cases originating from the Medical Information Call Center.
- Ensure proper triage, evaluation, and documentation.
8. Regulatory Compliance
- Ensure adherence to global pharmacovigilance regulations (FDA, EMA, ICH).
- Maintain documentation standards aligned with company SOPs.
