Houben Healthcare Consultancy provides independent pharmacovigilance consulting services and specialist drug safety expertise to pharmaceutical companies, marketing authorisation holders and pharmacovigilance service providers worldwide.
With over 22 years of professional experience in pharmacovigilance and a Master’s degree in Medical Biology, Remco Houben combines scientific expertise with extensive practical experience in global and local pharmacovigilance activities.
Consultancy services are tailored to the requirements of each organisation and may include specialist scientific assessments, regulatory safety documentation, operational support, independent quality review and pharmacovigilance process improvement.
Specialist Expertise in Global Pharmacovigilance
Houben Healthcare Consultancy provides specialist support across several areas of global pharmacovigilance, with particular expertise in signal detection and management, aggregate safety reporting, benefit-risk assessment and European Risk Management Plans.
A key aspect of this expertise is the ability to interpret scientific and regulatory information within the specific context of a medicinal product, taking into account its established safety profile, regulatory legal basis and stage in the product lifecycle.
Signal Detection and Management
Signal detection and management represent a key area of expertise, supported by extensive experience in routine and targeted signal surveillance, signal validation, evaluation and the preparation of scientifically substantiated Signal Evaluation Reports.
A central element of this expertise is the ability to interpret safety data within the specific context of a medicinal product. This requires a thorough understanding of the product’s established safety profile, regulatory legal basis, stage in the product lifecycle, therapeutic indication and available clinical and post-marketing safety information.
A sound understanding of the existing safety profile is essential for distinguishing genuinely new safety information from previously established associations and for recognising new aspects of known associations.
This product-specific perspective supports scientifically meaningful signal detection and evaluation, rather than relying solely on numerical trends or predefined statistical thresholds.
Experience covers both innovator medicines and products authorised under other regulatory legal bases, including generic products. Particular emphasis is placed on applying proportionate, risk-based surveillance strategies that reflect the characteristics of the product, the maturity of its safety profile and the nature and limitations of the available data.
Practical expertise includes working with various pharmacovigilance and signal detection systems, including Empirica Signal, LifeSphere Advanced Signals (LSAS), Spotfire and EudraVigilance/EVDAS.
Signal Detection Process Improvement and Implementation
In addition to performing signal detection activities, Remco Houben has experience supporting the optimisation and implementation of signal surveillance processes within a global pharmaceutical organisation.
This included supporting the transition from Empirica Signal to LSAS/Spotfire, comprehensively revising an existing Signal Detection Job Aid and adapting surveillance workflows and documentation practices to a new analytical environment.
The work covered different signal surveillance methodologies, including designated medical events, targeted medical events, data mining, special situations and broader safety surveillance assessments.
Particular attention was given to improving workflow clarity, promoting consistent scientific interpretation, supporting efficient documentation and developing practical guidance for pharmacovigilance personnel.
Activities also included the development and delivery of Spotfire training.
This combination of scientific expertise, operational experience and process improvement enables Houben Healthcare Consultancy to support organisations not only in conducting signal surveillance activities, but also in improving how these activities are performed, interpreted and documented.
Aggregate Safety Reporting and Benefit-Risk Assessment
Extensive experience is available in the preparation, scientific review and quality control of aggregate safety documents, including Periodic Safety Update Reports (PSURs/PBRERs), Development Safety Update Reports (DSURs) and other regulatory safety assessments.
Support may include cumulative safety data evaluation, scientific literature assessment, evaluation of safety concerns, benefit-risk assessment and preparation of responses to regulatory authority questions.
Assessments are performed with consideration of the available evidence, the established benefit-risk profile, the characteristics of the treated population and relevant regulatory requirements.
Risk Management Plans (RMPs) and Regulatory Strategy
Houben Healthcare Consultancy provides specialist support for the preparation, review and quality control of European Risk Management Plans (RMPs), with particular expertise in the application of EU Good Pharmacovigilance Practices (GVP) Module V and the relevant EMA RMP templates.
Experience covers medicinal products authorised under different regulatory legal bases, including innovator, generic and hybrid products. This includes an understanding of how the applicable regulatory requirements, product characteristics and available safety information influence the scope and content of an RMP.
Particular expertise has been developed in interpreting and applying both historical and current EU RMP formats, ensuring that individual sections and annexes are appropriately completed in accordance with applicable regulatory requirements.
This includes assessing the appropriate presentation of safety concerns, missing information, pharmacovigilance activities and risk minimisation measures, as well as ensuring consistency across the different parts of an RMP.
A key focus is on producing regulatory-compliant, scientifically sound and proportionate RMP documentation , avoiding unnecessary complexity while ensuring that all relevant requirements are adequately addressed.
Additional Pharmacovigilance Support
In addition to these specialist areas, Houben Healthcare Consultancy can provide support with other pharmacovigilance activities, including individual case safety reporting, medical literature monitoring, regulatory intelligence, reference safety information review, pharmacovigilance procedures and quality-related activities.
Support can be adapted to the scope of the assignment and the specific needs of the organisation.
Flexible Support for Pharmaceutical Companies
Pharmacovigilance requirements vary between organisations and may change over time due to regulatory deadlines, evolving product portfolios, increased workload or the need for specialist expertise.
Houben Healthcare Consultancy provides flexible support for pharmaceutical companies and pharmacovigilance service providers, ranging from individual scientific assessments to ongoing operational responsibilities and specialist consultancy projects.
Assignments may include temporary reinforcement of pharmacovigilance teams, independent scientific review, regulatory safety deliverables, quality control activities or support with the improvement of established processes and workflows.
As an independent consultant, Remco Houben generally works within the pharmacovigilance systems, procedures and Quality Management System (QMS) of the client. Where required, support can also be provided in developing or improving relevant pharmacovigilance procedures and working instructions.
Local Pharmacovigilance Services in the Netherlands
In addition to global pharmacovigilance consultancy, Houben Healthcare Consultancy provides local pharmacovigilance support in the Netherlands.
This includes Local Person for Pharmacovigilance (LPPV) responsibilities, Dutch regulatory intelligence, local medical literature monitoring and other country-specific pharmacovigilance activities.
More information about these services and the relevant Dutch regulatory requirements is available on our dedicated LPPV Services in the Netherlands page.
Scientific Background and Professional Experience
Remco Houben has worked in pharmacovigilance since 2004, gaining over two decades of experience within the pharmaceutical industry and through independent consultancy assignments.
His academic background in Medical Biology provides a scientific foundation for the evaluation and interpretation of clinical and pharmacovigilance data.
Combined with extensive hands-on experience in global pharmacovigilance operations, international regulatory requirements and specialised safety databases, this enables a practical, scientifically grounded and regulatory-focused approach to drug safety.
The focus is on delivering reliable, well-documented and proportionate pharmacovigilance support that integrates effectively with the client’s existing processes and regulatory responsibilities.
Discuss Your Pharmacovigilance Requirements
Are you looking for an experienced pharmacovigilance consultant to support your organisation with specialist drug safety activities, regulatory safety documentation or pharmacovigilance process improvement?
Contact Houben Healthcare Consultancy to discuss your requirements and explore opportunities for collaboration.