Taratec Launches Pharmacovigilance Practice
Taratec, a leading life science consulting company providing integrated business, information technology, and regulatory compliance services and products, announced today the launch of its Pharmacovigilance Practice and the appointment of industry expert Steve Jolley as vice president and practice leader.
Taratec’s Pharmacovigilance Practice will help clients interpret and respond to emerging regulations, including FDA’s recent draft guidelines on “Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.” Taratec will focus on a risk-based approach to pharmacovigilance, assisting companies in evaluating policies, processes, systems, and infrastructure for pharmacovigilance. Risks will be identified and rated, and a mitigation plan developed. This approach will enable companies to identify potential safety signals quickly and to take the appropriate action to protect patient safety, minimizing risk throughout the product lifecycle.
Commented Jolley, “The pharmaceutical industry, together with regulatory agencies, is striving to improve the quality of their pharmacovigilance efforts and react quickly to potential safety signals. Key to meeting this challenge is to look beyond the collection, assessment, and reporting of adverse events and to focus on signal detection and risk management.” Added Jolley, “With 20 years of experience in the life sciences sector, Taratec has a broad-based understanding of the business and regulatory implications surrounding pharmacovigilance processes and systems and the capability to improve them.”
“Regulatory authorities are now requiring pharmaceutical companies to develop comprehensive pharmacovigilance strategies for their products,” added John H. Freeman, chief operating officer of Taratec. “Recent product license applications have been turned down due to inadequate pharmacovigilance and risk management plans.”
“Steve is an ideal leader for Taratec’s Pharmacovigilance Practice. He brings extensive knowledge of the processes, systems, and strategies that comprise all aspects of pharmacovigilance,” continued Freeman. “His expertise complements Taratec’s proprietary risk-based methodology and understanding of the processes and systems used across the drug development lifecycle.”
Jolley has 20 years of experience in the pharmaceutical arena. In 1985, he founded DLB Systems, a developer of software systems that managed drug development and adverse event reporting for more than 40 major pharmaceutical companies including Amgen, Aventis, Johnson & Johnson, Pharmacia, and Procter & Gamble. After DLB was acquired in 1997 by eResearch Technologies, Jolley founded Protocol Driven Healthcare, Inc., a provider of health management connectivity solutions for wellness and chronic care improvement programs.
He holds degrees in mathematics and computer science from Cambridge University, England.
ABOUT TARATEC
Taratec is a leading life science consultancy that provides integrated business, information technology, and regulatory compliance services to innovative pharmaceutical, biotechnology, and medical device organizations around the world. With an extensive suite of services and solutions, Taratec enables life sciences companies to bring products to market sooner and improve manufacturing efficiency while achieving compliance with FDA regulations. Taratec is headquartered in Bridgewater, NJ, with offices in Conshohocken, PA; Chicago, IL; Newton, MA; and San Juan, Puerto Rico. For more information, please visit www.taratec.com
