Nikhil Kulkarni

About Nikhil Kulkarni

As a Safety Science Analyst with end-to-end pharmacovigilance experience, I specialize in…

Experience

1. Safety Science Analyst

   Fortrea

   Apr 2025 — Present

   As a Safety Science Analyst, I gained hands-on experience in both Case Processing and Quality Review of safety cases. As a Case Processor, I specialized in handling spontaneous Individual Case Safety Reports (ICSRs) and was responsible for accurate and timely case processing in the global safety database. My responsibilities included performing detailed data entry of patient demographics, reporter information, suspect and concomitant drug details, adverse events, medical history, laboratory data, and case narratives. I also performed medical coding of adverse events using MedDRA and drug coding using WHO Drug Dictionary, ensuring the accuracy and completeness of safety data in compliance with ICH E2B Guideline requirements. In my role as a Quality Reviewer, I conducted peer reviews of safety cases to evaluate accuracy, consistency, and completeness of data in the safety database against source documents. This included reviewing adverse event reports for completeness and reportability, ensuring consistency between narratives and database fields, identifying and correcting data entry errors, initiating follow-up activities for additional information when required, and documenting observations through defect tracking systems. I also ensured appropriate documentation of delays and routing comments as per internal SOPs while maintaining high standards of data quality. Additionally, I contributed to team development by providing training and guidance to newly joined associates, supporting their onboarding and adherence to pharmacovigilance best practices.