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.

Selected CV

Managing Member,
Stephen A. Goldman Consulting Services, L.L.C.

  • Chair for North America, CSP Special Interest Area Community, DIA.
    • 2005 DIA Outstanding Service Award recipient
  • National Academy of Sciences Institute of Medicine Food and Nutrition Board Committee on Framework for Evaluating the Safety of Dietary Supplements
  • Distinguished Fellow of the American Psychiatric Association (DFAPA)
     

Director, Pharmacoepidemiology
    Knoll Pharmaceutical Company (Mount Olive, NJ)

Medical Director, MedWatch (Office of the Commissioner)
   U.S. Food and Drug Administration (FDA) (Rockville, MD)

  • Office of the Commissioner's Commendable Service Award
    Individual:
    “For continual development and fostering of efficient mechanisms to ensure the flow of information of information on new medical product safety issues from the Centers to MedWatch”
  • MedWatch Group:
    “For recognition of exceptional service in the development of efficient mechanisms to rapidly communicate new medical product safety information to health professionals.”
  • ICH-related activities: E2B; MedDRA®
  • FDA Task Force on Risk Management: Report to the FDA Commissioner
    “Managing the Risks from Medical Product Use: Creating a Risk Management Framework”

FDA/Uniformed Services University of the Health Sciences(USUHS)Staff Fellow in Clinical Pharmacology and Regulatory Drug Evaluation Sciences FDA/USUHS (Rockville/Bethesda, MD)

  • FDA's Commissioner's Special Citation/Harvey W. Wiley Medal
    “For exceptional service in furthering the goals of MedWatch through the development of the June 10, 1994 CDER Conference on The Management of Drug-Induced Disease”

Director, Consultation – Liaison Division, Dept of Psychiatry Clinical Assistant Professor of Psychiatry and Medicine
    Indiana University School of Medicine (Indianapolis, IN)

  • Fellow of the Academy of Psychosomatic Medicine (FAPM)

Fellow/Assistant Attending in Consultation-Liaison Psychiatry
     Montefiore Medical Center (Bronx, NY)

Latest Publications

  • Bate A, Brown EG, Goldman SA, Hauben M. Terminological challenges in safety surveillance.  Drug Saf 2012; 35(1): 79-84.
     
  • Goldman SA. Harmonizing safety reporting.  International Clinical Trials Spring 2011:56-63.
     
  • Goldman SA. U.S. Postmarketing pharmacovigilance compliance in the midst of regulatory uncertainty. Food Drug Law J 2007;62(3):513-528
  • Brown EG, Goldman SA. Preparing for regulatory inspection of company pharmacovigilance systems and practices in the European Union and United States. In Carson PA, Dent NJ (eds). Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA Professional. Cambridge, UK: Royal Society of Chemistry, 2007:57-71