As global consultant in the field of pharmacovigilance and drug safety for the last 25 years, I work with biotech and pharmaceutical companies to determine a realistic “benefit to risk” analysis of products in both clinical and post-marketed situations. Because of today’s complex drug safety problems, I approach the issues as an end-user and capitalize on my many years of experience to uncover hidden landmines and potentially costly delays. I enjoy working with small as well as large companies to serve as lead safety consultant and adviser – your Drug Safety Navigator. My background includes President and CEO of Integrated Safety Systems®, Inc. (ISS) and former Vice President of Research Triangle Institute – Health Solutions (RTI-HS). I recently coauthored Drug Safety Data -- How to Analyze, Summarize, and Interpret to Determine Risk with Dr. Bart Cobert. While working on the book, I reconnected with my passion for training the next generation of drug safety experts. I realized that there is little time in today’s world for on-the-job training so it is critically important to transmit and convey the data, knowledge, and experience of current pharmacovigilance practitioners through all available means.I am a frequent speaker and trainer at many industry seminars and forums such as Drug Information Association (DIA) and recently returned from China where he conducted seminars on “Adverse Event Reporting and Pharmacovigilance”.Specialties: Board Certified in Emergency Medicine and Internal Medicine; Past President of RTP Chapter of the American Academy of Pharmaceutical Physicians; Board of Directors for Arthritis Foundation, Carolinas Chapter. My Specialties:Drug safety/pharmacovigilance,Drug safety training Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS),Risk management, Drug development strategic planning, Periodic Safety Update Reports (PSURs),Developmental Safety Update Reports (DSURs).
Listed skills include Clinical Development, Drug Safety, Drug Development, Pharmacovigilance, and 42 others.