EU and Local QPPV Services 

Pharmacovigilance

According to EU Directive 2001/83/EC and EU GVPs, pharmaceutical companies must appoint a Qualified Person for Pharmacovigilance (QPPV) who resides in the EU, is continuously available, and has the authority to oversee the company’s pharmacovigilance system. 

PVpharm offers comprehensive QPPV services, including:

  • EU QPPV: Full or partial outsourcing of QPPV responsibilities, ideal for non-EU companies or during workload peaks and absences.
  • Deputy QPPV: Backup support in line with GVP Module I, ensuring continuity of QPPV responsibilities during absences.
  • Local QPPV in Spain: Required by Spanish regulations, this role serves as a permanent safety contact for the Spanish Medicines Agency (AEMPS) and supports local pharmacovigilance activities, including:
    • Managing local adverse event reporting and communications with regional PV centers
    • Liaising with AEMPS on safety and sales-related requests
  • Local PV Contact in Other Countries: PVpharm can also provide local pharmacovigilance contacts in the EAA (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and UK) and other non-EEA countries to support global compliance.