Kattendijke, Zeeland, Netherlands
Signal Detection Specialist with experience in both the industry and the regulatory field • Provided consulting and training on the implementation of signal detection functionality to pharmaceutical and biotechnology companies as well as regulatory agencies in the areas of postmarketing, clinical development and longitudinal database (EHR-based) signal detection • Worked with FDA CDRH on the introduction of signal detection for medical devices • Performed many successful ad-hoc signal detection projects for a variety of different companies Pharmacovigilance and Risk Management Expert with experience in the US, Europe and Japan • Successfully implemented pharmacovigilance systems in many companies globally • Provided worldwide pharmacovigilance consulting and training 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 academic institutions in the US, Europe and Japan • Member and past member of key industry organizations, for example CDISC Advisory Board, International Society for Pharmacoepidemiology (ISPE) Industry Council • Author of over 20 scientific papers as well as a book chapter in peer-reviewed scientific and other professional journals and textbooks Specialties: Safety Signal Detection, Pharmacovigilance, Risk Management, Drugs, Devices, Vaccines, Global, US, Europe, Japan Bass-baritone and webmaster at Luscinia Consort Bass-baritone at Alauda Kwartet
Pharmacovigilance and Quantitative Signal Detection, data analytics, data visualization, education, public awareness and consulting.
Providing advice on methods and procedures for quantitative safety signal detection and risk management.
Pharmacovigilance and Quantitative Signal Detection education, public awareness and consulting.
Pharmacovigilance and Quantitative Signal Detection education, public awareness and consulting.
Pharmacovigilance and Quantitative Signal Detection education, public awareness and consulting.