Pharmacovigilance and drug safety for your pharmaceutical company — trust in professional hands.
Drug safety is a matter of trust.
Your single point of contact for drug safety, the QPPV function and regulatory compliance — with guaranteed 24-hour availability within the scope of the functions assumed and carefully selected partners in Germany and abroad.
One partner for the entire
pharmacovigilance spectrum.
From a single service to a fully outsourced PV system — specialised, inspection-ready and without losses at internal interfaces.
Quality Assurance GVP/GDP
Setting up and maintaining the quality assurance system: SOPs and work instructions, process description, management of deviations and CAPA.
Strategic Consulting & M&A
Mergers and acquisitions in pharmacovigilance, optimisation of pharmacovigilance, risk management and quality assurance systems.
Start-up Consulting
Regulatory support for new companies in the pharmaceutical sector, for example cannabis wholesalers and manufacturers: contacts with authorities and applications, referral and recommendation of service providers, support with contract processing, process development and documentation.
Interim Management
Bridging staff shortages, taking over pharmacovigilance functions including management positions.
Three steps to an inspection-ready PV system.
Initial consultation
Free of charge and in confidence, we clarify your PV needs, your regulatory obligations and the timeframe.
Analysis & concept
We review your structures, identify gaps and design a tailored, inspection-ready PV set-up.
Implementation & operation
From the QPPV function to ongoing reporting — we take over, operate and keep you compliant.
Our values, your advantage.
“Pharmacovigilance is a matter of trust.”
We attach great importance to loyalty, fairness, discretion and respect for our clients. This results in our values and your advantages:
Professionalism
You bring expert knowledge and experience into your company.
Personal contact
You have ONE contact person for your project.
Availability
We are directly available for you and react quickly, reliably and flexibly. Within the scope of assumed functions, 24-hour availability is guaranteed.
Quality
Our services and work results are subject to our own transparent quality management system.
Extensive, specialised support
You benefit from our cooperation with carefully selected partners nationally and internationally. Therefore we have a solution for (almost) every pharmaceutical task.
Modern and up-to-date
We always have up-to-date hardware and software and use state-of-the-art media for the exchange of information and data. Data security is of particular importance. You save time and personnel resources — efficiency that pays off for you.
This is what diligence looks like.
From the sample to the evaluation — pharmacovigilance is precision work, every day, in every detail.
Tell us what it is about.
You describe your situation, we send you a quote with the scope of services and your contact person. Without obligation and in confidence.
A team that knows the industry from the inside.
Dr. Felicitas K.
As a food chemist with a doctorate degree and several years of experience in clinical studies, quality management and quality assurance, Dr. Felicitas K. has been with VigiPRO® GmbH since 2020 and supports the team as a pharmacovigilance manager.
Dr. Christian L.
Doctor of biology with many years of professional experience in pharmacovigilance as Graduated Plan Officer, as Qualified Person Responsible for Pharmacovigilance and as team leader. Since 2022, Dr. Christian L. has been working for VigiPRO® GmbH and supports the team as pharmacovigilance manager and as quality management representative.
Petra M.
As a veterinarian with more than 10 years of experience in practice, Ms. Petra M. supports VigiPRO® GmbH since 2022 as pharmacovigilance manager.
Tanja M.
Pharmacist with many years of professional experience in pharmacovigilance, including as deputy graduated plan officer and local QPPV for Switzerland and Austria. Since 2021, Ms. Tanja M. has been supporting VigiPRO® as a freelance PV manager.
Anita H.
Biologist with many years of experience in teaching, research and pharmacovigilance at pharmacovigilance service providers and pharmaceutical companies, including in a management role as deputy graduated plan officer. Ms. Anita H. has been supporting VigiPRO® GmbH as a pharmacovigilance manager since 2026.
Anja J.
As a graduate librarian with many years of experience in reviewing clinical publications, Ms. Anja J. joined VigiPRO® GmbH in 2021 as a pharmacovigilance assistant.
David N.
As a pharmacist with an additional Master’s degree in Digital Health (medical informatics) Mr. David N. has been working for VigiPRO® GmbH as Digital Transformation Manager pharmacovigilance since 2024.
Anna L.
As a trained industrial management assistant with many years of experience in executive assistance and as an authorized signatory with staff responsibility, Ms. Anna L. has been working at VigiPRO® GmbH as Executive Assistant since 2026.
Ikponmwosa A.
As Bachelor student of “Artificial Intelligence” Mr. Ikponmwosa A. has been supporting VigiPRO® GmbH as an IT-Specialist / Full-Stack Developer since 2026.
Dr. Schw.
Graduated veterinarian with many years of professional experience in pharmacovigilance, also in executive position as Graduated Plan Officer. Since 2022 Dr. Schw. is working as Pharmacovigilance Manager at VigiPRO® GmbH.
Mandates we have taken on.
We do not name our clients. In a pharmacovigilance mandate, confidentiality is not a courtesy but part of the service — which is why this list says what we did, not for whom.
EU QPPV / Graduated Plan Officer
For national and international marketing authorisation holders and distributors of medicinal products.
Graduated Plan Officer under Section 63a AMG
For several American pharmaceutical and biotech companies and for various pharmaceutical and specialty pharmaceutical companies from France, Great Britain, Israel, etc.
Medically Trained Person
For national and international marketing authorisation holders.
Creation of a new PSMF
For national and international marketing authorisation holders.
Update of the quality assurance system
Revision and creation of the pharmacovigilance SOPs, the PSMF, pharmacovigilance contracts and exchange agreements. Client: German affiliate of an international pharmacovigilance and regulatory consulting company.
Lead pharmacovigilance auditor
For national and international marketing authorisation holders, active substance and medicinal product manufacturers.
Pharmacovigilance in non-interventional studies
For one of the world’s largest research-based pharmaceutical companies.
Patient Safety Specialist
For various international research-based pharmaceutical companies.
GVP/GDP Regulatory Consultant
For various pharmaceutical start-ups.
Medical Writing
Pharmacovigilance expert reports for marketing authorisation holders and pharmacovigilance service providers.
Contract services
Training, medical consulting, data entry into pharmacovigilance databases, etc.
- Pharmaceutical companies
- Specialised service providers in Germany and abroad
- IT developers, programmers and database manufacturers (safety database, XEVMPD)
- Physicians and pharmacists
- Industry associations
- Authorities
- Specialised lawyers and consultants
… and an extensive network of experts in pharmacovigilance and regulatory affairs.
Carefully selected partners in Germany and abroad.
What we do not cover ourselves, we cover together: through our cooperation with specialised partners we have a solution for (almost) every pharmaceutical service.
MS Pharm s.r.o.
mspharm.eu(opens in a new window)PHARMSOFT Dr. B. Rodust GmbH
pharmsoft.de(opens in a new window)ZEINCRO Group
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CLINI Resource
cliniresource.com(opens in a new window)This website is climate-friendly.
For us, responsibility does not end with drug safety. This site is built so lean that each page view causes only around 0.11 g of CO₂ — around 83 per cent less than an average website. We do not just talk about sustainability, we measure it.
Talk directly to the experts.
Confidential and without obligation. We respond quickly, reliably and flexibly — urgent pharmacovigilance matters first.