Shivam Kohli

At Parexel International, I support patient safety through pharmacovigilance operations, ICSR processing, quality review, and safety data management across regulated markets.

I've reviewed and quality-assured 1,200+ ICSRs, identified and corrected coding errors in 360 cases, and helped improve database accuracy from 92% to 98%. My systematic quality work also contributed to a 20% reduction in case processing errors.

I deliver training on MedDRA coding, LSMV best practices, and SOP adherence, while resolving queries in LSMV and Veeva global databases. I use root-cause analysis and CAPA protocols to strengthen audit readiness, data integrity, and turnaround times.

I also support DSURs and regulatory submissions, manage Product Event Library and dictionary operations for 15+ products, and maintain compliance through MedDRA upgrades, WHO-DD updates, and license management.