STEPHEN A. GOLDMAN, M.D., FAPM, DFAPA Managing Member
Stephen A. Goldman Consulting Services, L.L.C.
Dr. Goldman is an independent consultant with extensive experience in academic/clinical medicine, public health, federal medical product safety regulation, and the pharmaceutical industry.
Since 2001, he has utilized this unique background and expertise to provide a wide range of medical product safety-related services to the regulated industry (including pharmaceutical and medical device companies), government, academia and associations worldwide. Link to Consulting Services
While at Knoll Pharmaceutical Company (Abbott Laboratories) he served as Director, Pharmacoepidemiology, with responsibility for developing pharmacoepidemiology safety research programs for both marketed and investigational products. This followed his initial tenure as Director, Corporate Drug Safety.
Prior to working at Knoll, Dr. Goldman spent over six years at the U.S. Food and Drug Administration (FDA). After completing an FDA/Uniformed Services University of the Health Sciences (USUHS) fellowship in Clinical Pharmacology and Regulatory Drug Evaluation Sciences, he was Medical Director of MedWatch, the FDA postmarketing surveillance and medical product safety information program for several years.
In this capacity, he was utilized by all Centers as an in-house medical product safety/ risk expert, and was an active member of the Task Force on Risk Management that wrote “Managing the Risks from Medical Product Use: Creating a Risk Management Framework” Report to the FDA Commissioner. Among the honors he received while at FDA were the FDA Commissioner’s Special Citation/Harvey W. Wiley Medal and the Commendable Service Award.
Before joining FDA, Dr. Goldman was Clinical Assistant Professor of Psychiatry and Medicine at Indiana University School of Medicine, where he served as Director of the Division of Consultation-Liaison (C-L) Psychiatry. Previously, he was a Fellow/Assistant Attending in C-L Psychiatry at Montefiore Medical Center (Bronx, NY).
He holds an academic appointment as Adjunct Assistant Professor of Psychiatry at USUHS, and is a Fellow of the Academy of Psychosomatic Medicine (FAPM) and Distinguished Fellow of the American Psychiatric Association (DFAPA).
Dr. Goldman has published extensively in the medical literature on such topics as medical ethics, psychiatric illness secondary to medical/neurological causation, drug-induced disease and medical education. His papers on pharmacovigilance, CSP (Clinical Safety / Pharmacovigilance) auditing/inspections, risk communication and safety-related procedural documents are considered standards in the field. Link to List of Selected Publications Available On Line .
He was a two time North America Chair of the Drug Information Association (DIA) CSP Special Interest Area Community, and was a 2005 DIA Outstanding Service Award recipient.
Dr. Goldman served on the National Academy of Sciences/Institute of Medicine Food and Nutrition Board Committee on the Framework for Evaluating the Safety of Dietary Supplements, and was a member of the World Health Organization Uppsula Monitoring Centre’s Signal Review Panel.
In 2003 he was named Outstanding Alumnus by the Honors Tutorial College at Ohio University.