Medical Review Physician 1 Job in Clinchoice

Medical Review Physician 1

Location: Bengaluru

Employment Type: Full-Time

About the Role

We are seeking a detail-oriented and experienced Medical Review Physician to join our pharmacovigilance team in Bangalore. In this role, you will be responsible for the medical evaluation of individual case safety reports (ICSRs) across multiple data sources and therapeutic areas, ensuring compliance with global regulatory standards and internal quality benchmarks.

Key Responsibilities

Medical Review & Safety Assessment

• Perform medical review of both serious and non-serious ICSRs, with a focus on seriousness, expectedness, causality, and narrative quality.
• Review ICSRs originating from multiple sources: spontaneous reports, literature, regulatory authorities, solicited sources, and clinical trials.
• Evaluate and verify the selection of adverse events from source documents, assign appropriate MedDRA codes, assess product labelling, and review narratives for accuracy and completeness.
• Support triage activities and determine seriousness and relatedness across assigned products.

Product & Process Expertise

• Maintain up-to-date knowledge of product portfolios and safety profiles across therapeutic areas, including Oncology, Respiratory, Immunology, Neuroscience, and Rare Diseases.
• Ensure timely completion of all medical review activities in line with regulatory timelines and service level agreements (SLAs).
• Contribute to process improvement initiatives, including implementation of quality control checks and feedback mechanisms.

Collaboration & Training

• Provide expert medical guidance to case processors, data entry associates, and quality reviewers to address queries and discrepancies.
• Mentor and train team members in GVP concepts, case processing standards, and disease-specific medical knowledge.
• Collaborate with internal functional teams and client therapeutic groups to resolve case-related issues efficiently.

Compliance & Quality

• Stay updated with ICH-GCP, GVP modules, 21 CFR, and other relevant regulatory guidelines.
• Deliver consistent, high-quality output while ensuring compliance with client-specific conventions and global safety standards.
• Take on additional tasks as assigned by the team lead/manager, adapting to shifting business priorities when necessary.

Candidate Profile

• Education: MBBS or MD is required.
• Experience: 2 4 years of hands-on experience as a Medical Reviewer for ICSRs.
• Regulatory Knowledge: Strong understanding of ICH-GCP, Good Pharmacovigilance Practices (GVP), 21 CFR, and other international regulatory requirements.
• Technical Skills: Proficient in MS Office Suite (Outlook, Excel, Word, PowerPoint).
• Soft Skills: Excellent analytical, communication, and mentoring skills; ability to work independently and as part of a cross-functional team.

Why Join Us?

• Be part of a high-impact team contributing to global drug safety.
• Collaborate across a wide range of therapeutic areas and product portfolios.
• Develop and grow within a supportive, knowledge-driven work environment.
• Engage in continuous learning and professional development in a critical area of healthcare.

Ready to make a difference in patient safety? Apply now and join us in advancing global pharmacovigilance.