Arnold J. Gordon, PhD is a leading authority on pharmacovigilance and drug safety.  Dr Gordon formed and headed the Pfizer International Drug Safety organization, and established one of the first pharmacoepidemiology departments in industry during his career at Pfizer Inc.  He later headed Pfizer Worldwide Harmonization where he was directly involved with shaping global research and regulatory policy with emphasis on clinical safety. He held senior management positions in clinical development, NDA preparation, data management, and biometrics. Among the therapeutic areas in drug development he managed are diabetes, hypertension, and infectious diseases. He has authored over 50 publications on chemistry, clinical research, and drug safety including authorship of two books, and publications in the Drug Information Journal, one of which was a seminal paper on worldwide clinical adverse experience regulations for the industry.  

Dr. Gordon has played a very active role at PhRMA, among other activities as its rapporteur for clinical safety topics at ICH and chair of the International Issues group of the Committee on Clinical Safety.  He is also a long-standing member and chief editor of the CIOMS (Council of International Organizations of Medical Sciences) Working Groups on Drug Safety, consisting of senior regulatory and industry representatives, which has produced seven reports as of 2007 whose influence on regulations and at ICH are widely recognized.  He has also been at the forefront of industry-wide efforts to confront the potential problems raised for pharmaceutical companies by the legislation and regulations on medical data privacy and confidentiality in the EU, US and elsewhere. He is a popular and frequent invited speaker at DIA (Drug Information Association), PERI (Pharmaceutical Educational Research Institute), and other courses and workshops, especially on a variety of drug safety, risk management, and data privacy topics.  He has been chair of the DIA Annual Meeting Track on Clinical Safety and Pharmacovigilance, and also serves on the advisory board of the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Center, Uppsala, Sweden).  He is a recipient of the Drug Information Association’s Outstanding Service Award and received the Association’s Distinguished Career Award.

Dr. Gordon received a Bachelor of Science degree in Chemical Engineering from Northeastern University, and Masters of Science and PhD degrees in Chemistry from New York University.  After serving two years as a Captain in the US Army and five years on the chemistry faculties of two Universities, he joined Pfizer where he spent his entire pharmaceutical career until developing a consultancy in 2002.