Medical safety and clinical safety leadership
Senior M.D. input for safety strategy, clinical safety oversight, safety governance, and medical decision-making in complex pharmaceutical programs.
Medical safety consulting for pharmaceutical companies
Van Hoek Medical
Senior M.D.-led consultancy focused on pharmacovigilance, drug safety, clinical safety, signal management, benefit-risk evaluation, and regulatory-facing safety documentation for pharmaceutical companies worldwide.
20+
Years in pharmaceutical safety and medical work
EMA/FDA
Medical support for regulatory milestones
Peru
Based in Peru, working globally
What we do
Independent senior medical safety support for pharmaceutical teams.
Van Hoek Medical is based in Peru and works globally with pharmaceutical companies. Consultancy is provided through Van Hoek Medical S.A.C. and delivered directly by an experienced Medical Doctor with more than two decades of focus on drug safety, pharmacovigilance, clinical safety, and post-marketing safety decision-making.
Services
Medical safety expertise across development and post-marketing work.
Signal management and benefit-risk medical evaluation
Medical assessment of emerging safety information, signal evaluation, risk minimisation, and benefit-risk conclusions for development and marketed products.
Aggregate reports and risk management plans
Medical review and hands-on support for DSUR, PSUR/PBRER, aggregate safety reporting, RMPs, and regulatory safety documentation.
Integrated safety analyses and submission support
Medical contribution to integrated safety analyses, submission packages, regulatory questions, and MAA/NDA-related interactions with EMA and FDA.
Medical review and compliance review
Scientific accuracy review, claims versus SmPC assessment, compliance review of promotional, educational, and medical materials, with a focus on safety and benefit-risk content.
Safety governance, training, and inspection readiness
Safety governance support, pharmacovigilance training, inspection readiness, and medical input for regulatory safety responses.
For pharmaceutical companies
When to contact Van Hoek Medical.
Senior safety capacity
When your safety team needs experienced medical input for a defined project, review cycle, or urgent milestone.
Safety signals
When emerging safety information needs medical interpretation, prioritisation, and documentation.
Regulatory milestones
When a submission, response, or inspection requires clear medical safety reasoning.
Aggregate reporting
When DSUR, PSUR/PBRER, or RMP cycles need senior medical review or authorship support.
Compliance review
When promotional, educational, or medical materials need medical review and compliance review with a safety focus.
Safety team readiness
When PV, clinical safety, regulatory, and medical teams need alignment before high-stakes safety work.
Contact
Discuss your safety need.
Pharmaceutical companies can use the form below for an initial safety inquiry. You can also connect via LinkedIn. If you are in Peru and interested in joining the team, use the Join us form instead.
Form submissions are handled by Van Hoek Medical S.A.C. for initial screening and follow-up only. Data is not used for marketing. See the privacy notice for details on what is collected, how long it is kept, and how to request access or deletion.
Founder
Senior medical safety expertise, delivered directly.
Dr. Paul Van Hoek
Medical Doctor · Pharmacovigilance, drug safety, and clinical safety
The consultancy is led directly by Dr. Paul Van Hoek, a Medical Doctor with senior experience in pharmacovigilance, drug safety, and clinical safety. Work has focused on clinical development and post-marketing safety, including signal management, aggregate reporting, safety governance, and regulatory-facing safety documentation.
Experience includes small molecules and advanced therapies, including CAR T cell therapy programs, with a consistent focus on patient safety, transparency, scientific rigor, and compliance with accepted pharmaceutical industry and regulatory standards.
Connect on LinkedInRelevant experience
- Global pharmaceutical programs
- EMA and FDA regulatory interactions
- MAA/NDA-related safety support
- Multidisciplinary safety governance
- Safety documentation and medical review support
How we work
Clear, confidential, and practical.
Direct M.D. involvement
Pharmaceutical clients work directly with the physician consultant responsible for medical safety judgment and oversight.
Project or ongoing support
Engagements can be shaped around a defined deliverable, a review cycle, or continuing medical support.
Scalable M.D.-supervised capacity
Where useful, defined safety project work is delivered by trained physicians and life scientists in Peru under direct senior M.D. supervision — giving clients scalable safety capacity without losing medical accountability.
Confidential first contact
Initial inquiries should avoid patient data or confidential product details until appropriate arrangements are in place.
Join us in Peru
Pharmacovigilance and drug safety training in Peru.
Van Hoek Medical is building a small team of Peru-based physicians and life scientists trained for careers in drug safety, pharmacovigilance, and clinical safety work for global pharmaceutical clients. Training is practical, supervised by a senior M.D., and followed by real safety project work as skills develop.
Physician track
For Medical Doctors in Peru who want to move from clinical practice into pharmaceutical safety, pharmacovigilance, and drug safety careers.
- Licensed or recently graduated physician in Peru
- Interested in drug safety, clinical safety, and safety review
- Strong in English reading and writing
Life scientist track
For biologists, pharmacists, biochemists, and related graduates who want structured safety work under medical supervision.
- Life-science or pharmacy background
- Interested in safety documentation, data review, and report support
- Careful with scientific accuracy and detail
Safety training areas
- Medical safety and clinical safety
- Signal management and benefit-risk evaluation
- DSUR, PSUR/PBRER, RMPs, and aggregate reporting
- Integrated safety analyses and submission support
- Medical review and compliance review
- Safety governance, training, and inspection readiness
Express your interest
If you are based in Peru and want to be trained in pharmaceutical safety work with Van Hoek Medical, use this form for initial screening.