STEPHEN SUN, Vice-President, US Pharmacovigilance, Epidemiology and Risk Managment, PharmaLex

Dr. Sun earned his Bachelors of Science in Chemistry, Food, and Nutrition from Rutgers University, his medical degree from Rutgers-New Jersey Medical School, and his Masters in Public Health from Johns Hopkins. While training in general surgery at Beth Israel Medical Center in New York City, he dedicated his off-hours to developing a medical internet start-up. He eventually left residency to work full-time on his medical knowledge company, Medtower, which delivered relevant late-breaking news to research scientists in the life sciences.

Dr. Sun then transitioned to work for pharmaceutical companies, including Organon, Alpharma, and Reckitt-Benckiser and led up teams in Pharmacovigilance, Clinical Research, and Medical Affairs. With an interest in public health, Dr. Sun served as a Medical Officer in the FDA CDER’s Division of Risk Management (DRISK) and the Controlled Substances Staff (CSS) and led/participated in analysis of the TIRF class REMS, originating a proposed safety surveillance system using mobile technology called Realtime Application for Portable Interactive Devices (RAPID), and defining a proposed decision tree for the assessment of abuse potential of drugs.

While at Syneos Health, his continual interest included the development of a continuously-learning risk management system called WebRACT™ for clinical studies and published a paper on a Net Benefit Score using a Quantitative Model of FDA's Benefit-Risk Framework. He now serves as the VP of Pharmacovigilance, Epidemiology, and Risk Management for Pharmalex-US, Practice Area Lead for Benefit-Risk Management at Cencora-PharmaLex, and plays a lead role in the rapid configuration and deployment of end-to-end safety systems for US and global clients.