Houben Healthcare Consultancy was founded in 2017 by Remco Houben, an independent pharmacovigilance consultant with over 22 years of professional experience in drug safety and pharmacovigilance. Remco holds a Master’s degree in Medical Biology, providing a strong scientific foundation for his work in pharmaceutical safety.
Remco began his pharmacovigilance career in 2004 at N.V. Organon, which subsequently became part of Schering-Plough and later Merck/MSD. During this period, he held various positions within Global Drug Safety and Pharmacovigilance, gaining extensive experience in case processing, literature surveillance, signal detection and evaluation, aggregate safety reporting, and risk management.
He subsequently worked for specialised regulatory affairs and pharmacovigilance consultancy organisations before joining Astellas as a Global Medical Safety Manager. In 2017, he established Houben Healthcare Consultancy to provide independent pharmacovigilance consulting services to pharmaceutical companies and PV service providers worldwide.
Since establishing his consultancy, Remco has undertaken a wide range of international assignments, including roles as Associate Medical Safety Director, Medical Safety Scientist, Global Product Responsible Person, Signal Management Officer and Deputy EU Qualified Person Responsible for Pharmacovigilance (QPPV). Alongside these global responsibilities, he has extensive experience providing Local Person for Pharmacovigilance (LPPV) services in the Netherlands. His work has covered global and local product safety, benefit-risk assessment, signal management, regulatory compliance and pharmacovigilance process improvement..
Throughout his career, Remco has collaborated closely with multidisciplinary teams, including Clinical Development, Pharmacoepidemiology, Regulatory Affairs and Medical Affairs. His experience spans numerous therapeutic areas, including anti-infectives, oncology, autoimmune diseases, transplantation, central nervous system disorders, urology, dermatology, cardiovascular diseases and women’s health.
Having worked within both large pharmaceutical organisations and specialised consultancy environments, Remco is familiar with different pharmacovigilance systems, processes and organisational structures. This enables him to integrate efficiently into existing teams and provide effective support within established pharmacovigilance frameworks.
Combining a strong scientific background with extensive hands-on experience, Remco brings together operational expertise, medical and scientific safety assessment skills, and regulatory knowledge. His understanding of international pharmacovigilance requirements, including ICH guidelines and EU Good Pharmacovigilance Practices (GVP), enables him to provide practical, scientifically grounded support at both operational and strategic levels.