Rupam Pandey

Pharmacovigilance and healthcare operations professional with 12 years of experience, including 7+ years in end-to-end ICSR case processing and quality review. Experienced in spontaneous, literature, clinical-trial, and post-marketing cases; MedDRA coding; medical narrative writing and review; seriousness, causality, expectedness, and listedness assessment; reconciliation; and submission readiness. Proficient in Oracle Argus Safety, ArisG, and LifeSphere MultiVigilance, with working knowledge of FDA, EMA, ICH E2B, SOP, CAPA, audit, and inspection requirements.

Senior Drug Safety Associate & Quality Reviewer - Pharmacovigilance at Tata Consultancy Services Limited (2019-06 – Present)

• Manage end-to-end processing of Individual Case Safety Reports (ICSRs), including spontaneous, literature, clinical-trial, and post-marketing cases.
• Perform case intake and triage, duplicate searches, data entry, follow-up management, MedDRA coding, and narrative development for initial and follow-up reports.
• Review source documents and accurately capture patient, reporter, product, event, medical history, laboratory, treatment, and outcome information in the safety database.
• Evaluate and document seriousness, causality, expectedness, listedness, and company causality in line with product labeling, SOPs, and global regulatory requirements.
• Prepare and review medically coherent narratives that present complete clinical context and a clear chronological sequence of events.
• Conduct detailed case quality control and peer review covering completeness, consistency, coding accuracy, narrative quality, source-data alignment, and submission readiness.
• Identify processing and quality gaps, provide clear reviewer feedback, support corrective updates, and promote consistent application of SOPs and work instructions.
• Support timely submission of expedited and non-expedited reports to health authorities and business partners in accordance with FDA, EMA, and ICH E2B expectations.
• Perform clinical-trial, literature, and regulatory reconciliation; investigate discrepancies; and maintain clear documentation through closure.
• Support audit and inspection readiness, CAPA activities, and quality-improvement initiatives.
• Provide training, mentoring, and day-to-day guidance to junior associates; support workload distribution and performance monitoring.

Clinical Data Abstraction Specialist at IKS Health Solutions (2015-01 – 2019-05)

• Abstracted clinically relevant information from patient records and electronic health records, maintaining accuracy, completeness, consistency, and quality through structured review.
• Interpreted clinical documentation, applied medical terminology, identified documentation gaps, and supported reliable healthcare data capture.

Medical Coder at GeBBS Healthcare Solutions (2014-06 – 2015-07)

• Reviewed medical records and translated clinical documentation into standardized medical codes while resolving documentation gaps and maintaining quality-focused completion.
• Applied coding guidelines, medical terminology, and quality checks to support accurate and compliant healthcare data.

Post Graduate Diploma in Clinical Research – Imperial Institute of Clinical Research (2013-01 – 2014-12)

Bachelor of Pharmacy in Pharmacy – Rajiv Gandhi College of Pharmacy (2009-01 – 2013-12)