Find providers for Pharmacovigilance services. The list does not claim to be complete and no guarantee can be given for the correctness and up-to-dateness of the information provided. Furthermore, please note that this list does not have any recommendatory character.

If you are a provider of services in this area, you have the possibility to register free of charge in this directory.

Michor Consulting and Trade Services GmbH

Schönbrunnerstrasse 238/2/6

1120 Wien



  • Expedited reporting 
  • PSUR reporting 
  • Responding to information requests form the competent authorities
  • Handling of urgent safety restrictions and safety variations
  • Continuous monitoring of the safety profile of authorised medicinal products and notifying competent authorities and health professionals of changes in the risk/benefit assessments
  • Meeting CHMP commitments (for centrally registered products)
  • Maintaining internal audits of the pharmacovigilance system

Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster




  • Responsibility as EU qualified person for pharmacovigilance (EU QPPV)
  • Responsibility as a local QPPV in Germany (Stufenplanbeauftragter), Austria, the Netherlands, Belgium and Luxembourg
  • Development of Pharmacovigilance systems 
  • Preparation and Maintenance of Pharmacovigilance System Master File (PSMF), Summary PSMF (S-PSMF) and standard operating procedures (SOP) n
  • Assistance with competent authority inspections, self-inspections and audits
  • Management and evaluation of adverse events and complaints 
  • E2B (R3)-compliant processing and reporting of ICSRs
  • Literature research
  • EudraVigilance database monitoring for authority reports and signals
  • Signal management and continuous benefit-risk analysis 
  • Periodic safety update reports (PSURs)
  • Risk management plans (RMPs) and risk minimisation activities (such as educational material)
  • Company core data sheet (CCDS) and product information
  • Data submission and maintenance in the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD)
  • Contract management, such as the preparation and maintenance of safety data exchange agreements (SDEAs)
  • Pharmacovigilance training

ELC-Group s.r.o

Karolinská 650/1,

186 00 Prague 

Czech Republic


  • Establishment and maintaining of pharmacovigilance systems
  • Case Processing
  • Signal Management
  • Literature search
  • Medical information
  • EU QPPV (Qualified person for pharmacovigilance)
  • Pharmacovigilance audits
  • Medical Writing

ProPharma Group GmbH

Siemensdamm 62

13627 Berlin

Telefon: 030/856 06878-0


ProPharma Group GmbH is a leading consultancy and project management organisation in the fields of (bio)pharmaceutical products, medical devices, and healthcare.

Contact us in any phase of your product's lifecycle if you are looking for a partner in Product Development, Regulatory Affairs, (Pharmaco)vigilance or QA/QC.

  • Adverse Event Management (pre- and post-authorization)
  • Qualified Person for PV (EU and local)
  • Periodic reports (PSURs, DSURs, other safety reports)
  • Risk Management Plans
  • PV training and education
  • SOP writing and literature review
  • PV System Master File set-up 

Logo Pharmexon

Pharmexon Consulting s.r.o,

Krakovska 22 Prague 1

11000 Prague



  • Establishment of a EU-QPPV or Local QPPV in various EU countries
  • Gap-Analysis, Elaboration and Maintenance of the PSMF and other PV SOPs;
  • Establishment of the Qualified Person / Responsible Person for EudraVigilance including the xEVMPD Registration and the Establishment of the ICSR electronic Reporting;
  • Elaboration of the Technical Agreements - Safety Data Exchange Agreement;
  • Elaboration of CIOMS Reports;
  • Signal Management;
  • Compliance Reports;
  • Local and Worldwide Literature Monitoring;
  • Periodic Reconciliation with the Clients;
  • Pharmacovigilance in Clinical Trials;
  • Performance of Pharmacovigilance Audits and issuance of the applicable Audit Reports;
  • Periodic Safety Update Reports;
  • Elaboration of Risk Management Plans (QPPV drafting, assessment or renewal updates, signatory service in case of full-service PV);
  • Local QPPV in countries with the mandatory (in EU) requirements (BE, BG, HR, CY, CZ, DK, FR, EL, HU, LV, LT, NL,PL, PT, RO, SK, ES)

PharmaLex GmbH

Harrlachweg 6

68163 Mannheim



PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.


We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide. 


The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.


  • Pharmacovigilance & Clinical Safety
  • ICSR management, including collection, evaluation, processing, distribution and reporting (incl. validated safety database)
  • Signal management
  • Risk management
  • Periodic safety reports
  • Pharmacovigilance system and compliance
  • EU-QPPV, local QPPV
  • Quality system, audit and inspection support
  • Safety data exchange agreements
  • Pharmacoepidemiology
  • Literature Surveillance