Judy Hsiung

Head, Safety & Pharmacovigilance Practice

Dr. Judy Hsiung has upwards of twenty years of experience in the Global Pharmacovigilance (PV) and Risk Management space. She has a strong focus on PV organizational design and driving cross-functional teams to be prepared for critical global PV processes. Such processes include developing signal detection activities, aggregate safety report preparation and risk management (including RMP development) for investigational and marketed products. She has extensive experience with worldwide regulatory agencies including MHRA, BfArM, PMDA, FDA and SFDA. 

 

Dr. Hsiung has led the Global Safety organizations within various pharmaceutical companies during her tenure including, most recently, as Vice President, Head of Safety and PV at Arena Pharmaceuticals.  Previously, she was Acting Head of Global Medical Safety at Otsuka Pharmaceuticals where she led a team of ten physicians globally.  Judy was also instrumental in helping to design global PV processes while at CSL Behring Inc. and has direct PV submission experience.  Additionally, she has extensive experience in developing strategy for ideal benefit-risk lifecycle product management, as well as risk management planning for EU and Core RMPs for multiple compounds in indications including Oncology and CV-Hematology.  

 

Dr. Hsiung started her career in Pharmacovigilance & Risk Management as a Senior Drug Safety Associate at Hoffmann La Roche, working with a team of epidemiologists on risk management for Accutane. She also collaborated with the Anti-Viral Drug Advisory Committee on Hepatitis C. She later served as a Senior Clinical Safety Scientist at Bristol Myers Squibb, authoring multiple aggregate safety reports for the oncology products.  

 

Judy is dynamic and energetic. She brings both strategic and tactical expertise to any safety project thanks to her vast experience in PV operations and PV science.  Judy has consulted with many clients including equity and financial evaluations of PV outsourcing models and due diligence.  She holds a Doctorate degree in (Podiatric) Medicine from Temple University and a Bachelor of Arts degree in Biological Sciences from the University of Virginia.  

LSM Consulting is a safety and training consultancy working in the pharmaceutical and medical device sectors. It has been operating in the United States serving international clientele since 2008.

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