About Us
Let my Pharmacovigilance experience work for you
Dr. Doreen Lechner is a pharmacovigilance professional with over 30 years of industry experience in all areas of clinical trial and post-marketing drug safety. With her indepth knowledge of FDA and EMA pharmacovigilance regulations she has built focused pharmacovigilance teams while maintaining regulatory compliance. She has extensive experience in reducing the complexity of the drug safety business to bring innovative and cost-effective solutions to address global operational pharmacovigilance challenges.
Doreen holds the appointment of Program DIrector and Assistant Professor for the Biopharma Educational Initiative MS Clinical Trial Sciences Program at Rutgers University School of Health Professions.
Prior to forming DWL Consulting, she served as the Vice President- Pharmacovigilance of a safety CRO for 15 years as well as held management positions at Bristol-Myers Squibb, Schering–Plough and Ayerst Pharmaceuticals in the areas of Regulatory Affairs, Drug Safety and Pre-Clinical Drug Metabolism, Doreen received her undergraduate degree from Seton Hall University and her doctoral degree in Pharmacology from Rutgers University - Graduate School of Biomedical Sciences.
A Sampling of Doreen's PRESENTATIONS, TRAININGS and WEBINARS are noted below:
Pragmatic Approaches to Drug Safety Across the Premarketing and Post-Marketing Continuum. DIA Training – Princeton, New Jersey. December 2014
Post-Marketing Drug Safety and Pharmacovigilance. DIA Training – Denver, Colorado. November 2014
ABC’s Of The Pharmacovigilance System Master File. DIA Annual 2014 Meeting – San Diego, California. June 2014
Telerx Boosted Patient Safety And Created A Transparent Customer Experience Using PEGA’s Adverse Event Case Processing. Pega WORLD 2014 - Washington, D.C. June 2014
Safety Reporting And Global Regulatory Update. Sentrx Annual 2013 User Conference – Orlando, Florida. November 2013
Focus On Providing Outstanding Client Service. Sentrx Annual 2012 User Conference – Orlando, Florida. November 2012
Pharmacovigilance System Master File. Sentrx Annual 2012 User Conference – Orlando, Florida. November 2012
Pharmacovigilance Regulation And Guidance Update. Sentrx Annual 2011 User Conference – Orlando, Florida. November 2011
Important Medical Event List: A MedDRA Based Approach. Sentrx Annual 2011 User Conference – Orlando Florida. November 2011
Meeting International Safety Reporting Requirements. Barnett Conference- Webinar. March 2011, June 2010, February 2010