KARTHIK MUTHUSAMI, Sr.Director, Head of Expedited Safety Reporting, Bristol-Myers Squibb

•   Karthik serves as the Senior Director for Expedited Safety Reporting at Bristol-Myers Squibb (BMS) Company in Princeton, NJ. With 18 years of experience in the pharmaceutical industry, Karthik has held various leadership roles within ICSR operations, Quality & Compliance, and Risk Management.
•   He has successfully led multiple projects involving harmonization and integration of ICSR databases/processes. Additionally, Karthik plays a crucial role in overseeing vendor teams and defining the outsourcing strategy. Leading a team of Safety Scientists, Karthik is responsible for the handling and management of Expedited Safety Reports and SUSARs.
•   Karthik actively participates in the review and implementation of Regulatory Policy Changes that impact GCP and GVP processes. He has a passion for system automation and is dedicated to implementing innovative processes to enhance operational efficiencies.
•   Furthermore, Karthik is an engaged member of cross-functional industry consortiums such as TransCelerate, contributing to collaborative efforts within the pharmaceutical industry.