Pharmacovigilance

Pharmacovigilance

In the area of Pharmacovigilance we provide the following services:

  • Provision of Qualified Person Responsible for Pharmacovigilance (QPPV) for the European Economic Area (EEA QPPV) and Deputy EEA QPPV
  • MAH registration to the Eudravigilance database
  • Management of Individual Case Safety Reports
  • Preparation and submission of Aggregate Safety Reports
  • Monitoring of product safety
  • Organizational issues of Pharmacovigilance department
  • (Writing and/or reviewing of Standard Operating Procedures and “Detailed Description of Pharmacovigilance System”)
  • Risk Management System
  • Pharmacovigilance audits/inspections
  • Pharmacovigilance training
  • Medical Information