Pharmacovigilance Expert with experience in the US, Europe and Japan • Successfully implemented pharmacovigilance systems in many companies globally • Provided worldwide pharmacovigilance consulting and education to pharmaceutical, biotechnology and medical device companies as well as contract research organizations and academic institutions Quantitative Safety Signal Detection Specialist with experience in both industry and regulatory environments • Provided guidance through both education and consulting to many pharmaceutical and biotechnology companies as well as regulatory agencies (FDA, MHRA) on the implementation of quantitative safety signal detection methodologies based on postmarketing, clinical and observational databases • Worked with FDA CDRH on the introduction of safety signal detection methods for medical devices • Performed a range of successful ad-hoc signal detection projects for a variety of different companies Global Opinion Leader in the field of pharmacovigilance and safety signal detection • Regularly delivering presentations and workshops at industry conferences and events as well as lecturing at academic institutions in the US, Europe and Japan • Member of key industry advisory organizations such as the CDISC Advisory Board and the International Society for Pharmacoepidemiology (ISPE) Industry Council • Frequently published in peer-reviewed scientific as well as other professional journals and textbooks (detailed bibliography available upon request)