Are my (bio)pharmaceutical assay performances reliable? Only probability of success counts!
The addition of this service allows the Group to drive its specialist drug safety expertise within the US
Friedrichsdorf / Philadelphia, January 31st 2017: As of 17th January, 2017, the PharmaLex Group, a leading specialist provider of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance, has enhanced its service portfolio in the US with the addition of a key specialist in the field of Pharmacovigilance.
Wenda Brennan joins PharmaLex as Head of Pharmacovigilance Services, North America. Wenda has over 30 years of pharmaceutical experience, the past 18 years concentrated in Safety and Risk Management. Her experience includes implementing and managing safety departments to support all safety activities for studies, registries and spontaneous reporting programs. She has overseen the safety case processing for thousands of products and has provided consulting services to new companies developing safety departments in establishing processes and SOPs. Additionally, Wenda has directed several product recall operations for bariatric medicine, pain management and diabetes products.
Prior to joining PharmaLex, Wenda’s safety experience included launching the Phase IV Pharmacovigilance division of Covance, creating and overseeing a global service provider Pharmacovigilance department and providing PV leadership to C3iHC during integration of Sentrx Safety. In conjunction with the FDA, Wenda designed and implemented the iPLEDGE Risk Management program and has conducted project management and safety management activities for Risk Management Programs in the areas of dermatology, psychology, CNS, device and gastroenterology. In her experience she has overseen complex safety reporting requirements for 11 FDA mandated risk management programs.
Wenda received her degree in Pharmacy from the University of the Sciences in Philadelphia, Philadelphia College of Pharmacy and has held adjunct faculty appointments at the University of Delaware and University of the Sciences in Philadelphia.
In her current role at PharmaLex, Wenda is responsible for the development and growth of US safety services.
“The addition of Pharmacovigilance to the US service portfolio is an important development for us” explained Dr. Thomas Dobmeyer, CEO PharmaLex. “Wenda’s vast experience and expertise will allow us to expand our existing offer for our US clients, enabling us to provide a complete portfolio for regulatory and safety services during a product lifecyle from the initial development through to drug safety monitoring” added Dr. Tilo Netzer, CEO PharmaLex.
The PharmaLex Group now has over 500 employees, with 22 offices in 12 countries and more than 550 satisfied clients worldwide.
About PharmaLex <Confidence beyond compliance>:
PharmaLex combines local expertise with global reach in the area of scientific services, regulatory affairs and pharmacovigilance. A proven track record of success in outsourcing programs with more than 30,000 successfully completed projects for over 600 clients worldwide, as well as extensive experience in all therapeutic areas and product groups, including advanced therapy medicinal products and biopharmaceuticals, medicinal and borderline products and alternative therapeutic approaches.
For further information, please contact:
Ms. Jenna O’Nell
PharmaLex Development Services LLC; Director of Operations
jenna.onell@pharmalex.com
+1 (703) 963 1133
PO Box 149, Berwyn, PA 19312 USA
Ms. Eva Keck
PharmaLex GmbH; Director Business Development Operations
eva.keck@pharmalex.com
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim
Germany
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