MIAMI, June 15, 2016 /PRNewswire/ -- Biorasi, a CRO widely recognized for delivering success in complex clinical trials, today announced the enhancement of its Safety and Pharmacovigilance capabilities under the leadership of Mark Vieder, who has been promoted to Vice President, Drug Safety and Pharmacovigilance. A veteran of the U.S. Food and Drug Administration, Mr. Vieder joined Biorasi in October 2015 as Director, Drug Safety and Pharmacovigilance. Mr. Vieder has leveraged his Agency and industry experience to help cement Biorasi's position as a leading full-service contract research organization with the ability to assist sponsors in receiving, processing, and reporting critical safety information generated through clinical trials.
"Recognizing safety as a priority for all stakeholders involved in the development of drug products, Biorasi has built a best-in-class safety infrastructure staffed by a team of experienced Safety and Pharmacovigilance professionals dedicated to ensuring safety reporting is conducted in a timely, accurate, quality, and compliant manner. We're proud to have Mark leading that group," stated Boris Reznik, Ph.D., Chairman, Biorasi.
As Vice President, Drug Safety and Pharmacovigilance, Mr. Vieder brings a unique set of skills to the role. His experience with the FDA began as a contractor to the Agency in the receipt, triage, processing, and review of all case safety reports. In addition, Mr. Vieder has conducted training sessions involving MedDRA and the WHO Drug Dictionary at numerous pharmaceutical companies in the U.S. and abroad. He then became the Program Director for the FDA's post-marketing adverse event database (FAERS), and moving from contractor status into the FDA, Mr. Vieder continued to oversee the FAERS program and was a resource for many centers in the Agency, including the Office of Surveillance & Epidemiology, Office of New Drugs, Office of Generic Drugs, Office of Regulatory Affairs, and the Office of Compliance.
Prior to FDA, Mr. Vieder had been an active healthcare practitioner and practiced pharmacy for approximately 18 years in both the hospital and retail settings. He also has pharmaceutical industry experience, including stints at Parke-Davis/Warner-Lambert, Pfizer Pharmaceuticals, and Regeneron Pharmaceuticals
For more information on Biorasi's full service capabilities including an overview of the company's Safety and Pharmacovigilance services, please visit: http://www.biorasi.com/what-we-do/safety-and-pharmacovigilance.
Biorasi is a contract research organization (CRO) widely recognized for delivering success in complex clinical trials. This is possible through TALOS™, an innovative operating model that unifies systems and teams with a powerful project management methodology to ensure high quality delivery. Overall, Biorasi balances power, time, acceptance, cost and service level to optimize the delivery of clinical studies.
Global biopharmaceutical companies have come to depend on Biorasi to deliver their most complex studies. The company's expertise includes a range of molecule types, development phases, therapeutic areas, geographies, and development programs. Biorasi has collaborated with sponsors to enable FDA, EMA, and multi-venue approvals for numerous small molecules and biologics.
Biorasi, headquartered in Miami, Florida, maintains office-based teams around the globe. The company has received the coveted CRO Leadership Award from Life Science Leader magazine and has placed on the Inc. 500 list of America's fastest growing companies. For more information, visit www.biorasi.com.
Chief Marketing Officer