Looking for an experienced pharmacovigilance consultant?
Independent pharmacovigilance consultancy and drug safety expertise
Houben Healthcare Consultancy provides independent pharmacovigilance consulting and drug safety services to pharmaceutical companies and pharmacovigilance service providers worldwide.
Founded by Remco Houben, an experienced pharmacovigilance consultant with over 22 years of professional experience and a Master’s degree in Medical Biology, the consultancy offers flexible, scientifically grounded support across a broad range of pharmacovigilance activities.
Core areas of expertise include signal detection and management, aggregate safety reporting (PSURs, PBRERs, DSURs and PADERs), Individual Case Safety Report (ICSR) processing, risk management, literature monitoring, and pharmacovigilance regulatory intelligence.
Additional services include QPPV support, local pharmacovigilance services in the Netherlands (LPPV), and the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs) and pharmacovigilance procedural documents, including Standard Operating Procedures (SOPs).
Whether you require temporary operational support, specialist expertise for a specific project, or ongoing pharmacovigilance assistance, Houben Healthcare Consultancy offers a flexible and reliable solution tailored to your needs.
Learn more about the qualities of Houben Healthcare Consultancy
Hands-on
Providing practical, hands-on operational and strategic support across a broad range of pharmacovigilance and drug safety activities.
Meet your needs
Flexible pharmacovigilance consultancy services tailored to your specific requirements, from individual projects to ongoing operational support.
Focused
Committed to delivering accurate, scientifically sound and high-quality results in a timely and cost-effective manner.
Strong network
Access to an established professional network of experienced healthcare and pharmacovigilance specialists, enabling additional expertise when required.
Qualified
Remco Houben is an experienced pharmacovigilance consultant with over 22 years of professional experience and a Master's degree in Medical Biology. He has extensive experience within pharmaceutical companies and specialised pharmacovigilance service providers. Remco is also a member of the Dutch Association of Pharmaceutical Medicine (NVFG), which includes the Dutch Pharmacovigilance Platform (PPN).
About
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.
Services
Houben Healthcare Consultancy provides independent pharmacovigilance consulting services to pharmaceutical companies and PV service providers worldwide. With over 22 years of experience, Remco Houben offers extensive expertise in global drug safety, signal detection and management, benefit-risk assessment, aggregate safety reporting and regulatory pharmacovigilance activities.
In addition to global pharmacovigilance consultancy, Houben Healthcare Consultancy provides Local Person for Pharmacovigilance (LPPV) services in the Netherlands. As a Netherlands-based consultant, Remco Houben supports local pharmacovigilance responsibilities, including regulatory intelligence, literature monitoring and other country-specific PV activities. Services are tailored to individual project requirements and may include temporary assignments, specialist support or ongoing pharmacovigilance activities. Please contact Remco Houben to discuss potential collaboration.
For a detailed overview of specialist expertise and consultancy services, please visit the Pharmacovigilance Consulting Services page.
The scope of services includes, but is not limited to:
- Local Pharmacovigilance / LPPV Services – Netherlands: Local Person for Pharmacovigilance (LPPV) responsibilities, including local regulatory intelligence, literature monitoring and country-specific PV activities.
- EU QPPV Support: Support to the EU Qualified Person Responsible for Pharmacovigilance (QPPV), including Deputy EU QPPV responsibilities and PV system oversight.
- Signal Detection and Management: Signal detection, evaluation and management, including signal evaluation reports, EudraVigilance/EVDAS analysis, process improvement and coaching.
- Aggregate Safety Reporting and Medical Writing: Preparation, review and quality control of PSURs/PBRERs, DSURs, PADERs, RMPs, NDA annual reports and other pharmacovigilance or clinical safety documents.
- Global Product Safety and Benefit-Risk Assessment: Medical and scientific safety evaluation, ongoing product safety surveillance, benefit-risk assessments and global product safety management support.
- Risk Management and Risk Minimisation: Preparation, review and maintenance of global and local (EU) Risk Management Plans (RMPs), including risk minimisation measures and related documentation.
- Individual Case Safety Report (ICSR) Management: ICSR processing, medical review, quality control and case management, including EudraVigilance support.
- Global and Local Literature Monitoring: Scientific and medical literature screening for ICSR identification, signal detection and relevant safety information for aggregate reports.
- Reference Safety Information and Product Information: Pharmacovigilance and medical safety support for the review and updating of reference safety information, including Investigator’s Brochures (IBs), Company Core Data Sheets (CCDS), EU Summaries of Product Characteristics (SmPCs) and other regional product information, with a focus on safety-related content.
- Pharmacovigilance Systems and Procedures: Preparation and maintenance of Pharmacovigilance System Master Files (PSMFs), Standard Operating Procedures (SOPs), work instructions and other PV procedural documents.
- PV Regulatory Intelligence and Compliance: Monitoring Dutch and European pharmacovigilance regulatory developments, compliance support and responses to regulatory authority safety enquiries.
- PV Training and Process Improvement: Training, coaching and optimisation of pharmacovigilance processes, workflows and related documentation.
24/7 availability can be provided for designated LPPV and Deputy EU QPPV responsibilities, subject to agreed contractual arrangements.
Contact form
Contact
Remco Houben, MSc
Lupinenstraat 10
6942 VB Didam
The Netherlands
E: info@houbenhc.com
T: +31 (0) 6 14 32 84 73
Dutch Chamber of Commerce number: 68011776
VAT NL001813303B14