Pharmacovigilance services for national and international marketing authorisation holders.
VigiPRO covers human and veterinary pharmacovigilance: the pharmacovigilance system and its master file, responsible persons including EU QPPV, audits and inspections, risk management, periodic reports and literature screening.
This English page is an overview of what VigiPRO does. The detailed service pages, the request forms and the blog are published in German only.
Eleven services, from the pharmacovigilance system to interim management.
Pharmacovigilance Human and Veterinary
- Implementation of national and European pharmacovigilance requirements
- Creation / revision of the PSMF (Pharmacovigilance System Master File)
- Changes and reorganisation in case of outsourcing, mergers and acquisitions or process optimization
- Pharmacovigilance contracts and safety data exchange agreements (SDEA)
- Regulatory intelligence
Pharmacovigilance in Studies and Social Media
- Medical single case assessment
- Data management
- Evaluation of cumulative data / listings (reconciliation)
- Periodic reports (see “Reports”)
- MedDRA coding
Pharmacovigilance Audits / Inspections
- Pharmacovigilance audits of entire pharmacovigilance systems or parts thereof
- Audits of partners and service providers nationally and internationally
Quality Assurance (GVP, GDP)
- Creation / revision of the quality assurance system according to Good Pharmacovigilance Practice (GVP) and Good Distribution Practice (GDP)
- Creation / revision of quality documents (SOPs, WIs)
- Process description and optimization
- Management of changes, deviations, corrective and preventive actions (CAPA)
- SOP trainings and pharmacovigilance trainings
- Preparation of and support during pharmacovigilance inspections
Responsible Persons / QPPV
- Temporary or permanent assumption of the function or of the deputy function
- QPPV (human and veterinary)
- EU QPPV (GVP module I, I.C.1.3)
- Medically trained person (Regulation (EU) No. 520/2012 Art. 10 (1))
- Graduated Plan Officer (§ 63a AMG)
- Medical Information officer (§ 74a AMG)
- Responsible person for narcotic drugs (§ 5 BtMG)
- Guaranteed 24-hours-availability within the scope of the functions
Risk Management Systems
- Creation / revision of risk management plans
- Benefit / risk assessment of medicinal products
- National and European risk procedures (emerging safety issue, referral procedure)
- Risk minimisation measures
- Creation and implementation of “educational material”
- Signal detection
- Signal evaluation and documentation
Reports
- Periodic safety update reports (PSUR)
- Periodic benefit-risk evaluation reports (PBRER)
- Development safety update reports (DSUR)
Literature Screening
- Periodic literature screening
- Global (Medline, Embase)
- Locally in German speaking countries
- Locally in further countries in and outside the EU
Strategic Consulting
- Mergers and acquisitions in pharmacovigilance
- Optimisation and modification of the pharmacovigilance system, the risk management system and the quality management system
- Process optimization
- In- and outsourcing / integration of service providers
Start-up Consulting
- Regulatory consulting and support for start-ups in the pharmaceutical sector (e.g. cannabis wholesalers and manufacturers)
- Contact with authorities and license applications
- Procurement and recommendation of service providers
- Monitoring of the contract implementation
- Process development and documentation
Interim Management
- Bridging of personnel shortage
- Assumption of pharmacovigilance functions including management positions
- Responsible persons with deputy
The German website describes most of these services on a page of their own, with the underlying regulations and typical questions. See the German service pages.
Our values, and what they mean for you.
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.
“Pharmacovigilance is a matter of trust,” the founders of VigiPRO say.
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.
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.
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.
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.
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.
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.
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.
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.
An excerpt of our satisfied clients
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.
Revision and creation of the pharmacovigilance-SOPs, the PSMF, pharmacovigilance-contracts and -exchange agreements. Client: German affiliate company of an international pharmacovigilance- and regulatory consulting company.
national and international marketing authorisation holders and distributors.
multiple American pharmaceutical- and biotech companies and for various pharmaceutical and specialty pharmaceutical companies from France, Great Britain, Israel, etc.
studies for one of the world’s largest researching pharmaceutical companies.
national and international marketing authorisation holders, active substance- and drug manufacturer.
national and international marketing authorisation holders.
national and international marketing authorisation holders.
several international researching pharmaceutical companies in the world.
several pharmaceutical start-ups.
Pharmacovigilance Expert Reports for marketing authorisation holders and pharmacovigilance service providers.
training, medical consulting, data entry into pharmacovigilance databases, etc.
Clients, Partners and Contacts
- Pharmaceutical companies
- Specialised service providers nationally and internationally
- 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 the fields of pharmacovigilance and regulatory affairs.
We work with selected specialists.
Talk to us directly.
Tell us which function or which part of your pharmacovigilance system you need support with — by e-mail or by phone. Correspondence in English is no problem.
+49 202 25 85 91 80 (exchange)
+49 202 25 85 91 81+49 202 25 85 91 85
Fax: +49 202 75 25 87
Our online request form is available in German only.