Medical Reviewer Pharmacovigilance Bangalore/Chennai Job Summary We are seeking a Medical Reviewer with experience in Pharmacovigilance to perform medical review of Individual Case Safety Reports (ICSRs) and ensure high-quality safety data evaluation in compliance with global regulatory requirements. The ideal candidate will possess strong clinical knowledge, expertise in case assessment, and a thorough understanding of pharmacovigilance processes and applicable regulations. Roles & Responsibilities Perform medical review of Individual Case Safety Reports (ICSRs) received from spontaneous, literature, clinical trial, and other reporting sources. Conduct medical assessment of adverse events, including seriousness, expectedness, causality, and listedness in accordance with applicable regulatory guidelines. Review case narratives and ensure the clinical accuracy, completeness, and consistency of safety data prior to regulatory submission. Identify missing or inconsistent medical information and recommend appropriate follow-up where required. Ensure timely completion of medical review activities while adhering to regulatory timelines and internal quality standards. Collaborate with pharmacovigilance case processing teams, quality review teams, and cross-functional stakeholders to resolve case-related queries. Apply global pharmacovigilance regulations, company SOPs, and ICH guidelines during medical review activities. Support quality initiatives, audits, inspections, and compliance activities as required. Maintain accurate documentation of medical review decisions and ensure data integrity within the safety database. Participate in process improvement initiatives and contribute to enhancing operational efficiency and quality. Required Qualifications MBBS/MD qualification. Minimum 1+ years of relevant Pharmacovigilance experience. At least 1 year of hands-on experience in ICSR case processing. Experience in medical review of safety cases is preferred.



Valuable understanding of global and regional Pharmacovigilance regulations, including ICH guidelines and GVP. Familiarity with MedDRA coding, causality assessment, seriousness assessment, and benefit-risk evaluation. Experience with safety databases such as Oracle Argus, ARISg, or Veeva Vault Safety is an advantage. Strong analytical, clinical, and communication skills. Excellent attention to detail with the ability to manage multiple priorities and meet regulatory timelines. Preferred Skills Strong understanding of ICH E2A/E2B(R3), GVP, FDA, EMA, and other global pharmacovigilance regulations. Experience in medical review, case assessment, and quality review of safety cases. Ability to work effectively in a fast-paced, quality-driven environment while maintaining compliance with regulatory and organizational standards.

VDart: Digital Consulting & Staffing Solutions

VDart is a leading digital consulting and staffing company founded in 2007 and headquartered in Alpharetta, Georgia. VDart is one of the top staffing companies in USA & also provides technology solutions, supporting businesses in their digital transformation journey. Digital consulting services, Digital consulting agency

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With over 17 years of experience, VDart combines staffing expertise with technology solutions to help organizations modernize their operations and build skilled workforce capabilities across multiple sectors.

📌 Medical Reviewer (Chennai)
🏢 VDart Software Services
📍 Chennai