About Wendy Stephenson: Background and Expertise

Dr. Wendy Stephenson is a physician and epidemiologist with over 20 years of experience in pharmaceutical safety. From 1987 to 1997 Dr. Stephenson worked for Merck & Company, starting as Associate Director, Epidemiology Research and advancing rapidly to Executive Director, Worldwide Product Safety & Epidemiology. In 1997 she joined Wyeth as Vice President, Global Safety Surveillance & Epidemiology and in 1998 was promoted to Senior Vice President, adding Health Outcomes Research and Labeling to her responsibilities. During her tenure as a pharmaceutical executive Dr. Stephenson has helped to build safety organizations considered among the best in the industry. In addition to putting the necessary organization, procedures and systems in place for ensuring compliance with global regulatory requirements, she has had extensive experience managing important product safety issues from a medical, epidemiological and regulatory perspective.

In February 2004 Dr. Stephenson left Wyeth to start Wendy Stephenson & Associates LLC, which specializes in all aspects of pharmaceutical safety, by providing support and advice to pharmaceutical and biopharmaceutical companies. An adjunct appointment with the University of Pennsylvania Center for Clinical Epidemiology and Biostatistics offers the opportunity for collaboration with the Center to help clients meet specific research objectives.

Dr. Stephenson has been a member of the CIOMS Working Groups II - VII on clinical drug safety, beginning in 1990. The CIOMS Working Groups, under the auspices of the World Health Organization, have provided a forum for experts from industry, government and academia to address issues of mutual interest and concern. Published proposals often influence national legislation and industry practice. Dr. Stephenson served as Co-Chair of CIOMS VI which published its recommendations on “Managing Safety Information from Clinical Trials” in early 2005. She also participated in the development of some of the International Conference on Harmonization (ICH) efficacy and safety consensus documents.

Dr. Stephenson received her MD degree and Master of Science degree in Biometrics from Temple University Medical School.  She also has a Master of Public Health degree from the University of Massachusetts, earned while completing a residency in Preventive Medicine and is board certified in Preventive Medicine and Public Health.  Prior to joining the pharmaceutical industry, Dr. Stephenson was Assistant Professor of Medicine, Biostatistics and Epidemiology at the University of Massachusetts Medical Center.  Most recently, Dr. Stephenson received her MBA from the University of Pennsylvania Wharton School of Business with a concentration in Finance.

Dr. Stephenson has published in the field of drug safety and has been an invited speaker for various drug information forums.

View Wendy Stephenson's Curriculum Vitae »