Pharmacovigilance Services

  • A Qualified Person responsible for
    Pharmacovigilance (QPPV) / Deputy QPPV services
    (24 hour cover)
  • Safety Physician Services
  • Full and ad hoc PV services including:
    • Safety Data Exchange Agreements (SDEAs)
    • Risk Management Plans (RMPs)
    • Creation and Maintenance of Pharmacovigilance
      Safety Master Files (PSMFs)
    • Periodic Safety Update Report (PSUR’s)
    • Electronic PSUR Portal Registration & Submissions
      Signal Detection and Management

  • Individual Case Safety Report (ICSR) Processing
  • Monitoring, download, and processing of E2B-R3 reports.
  • Fully validated Pharmacovigilance Safety Database
  • Expedited Reporting to Authorities
  • EudraVigilance Set-up, Maintenance and
    registration
  • XEVMPD Maintenance
  • Company specific Standard Operating Procedure
    (SOP) Creation and Review
  • Weekly Literature Monitoring

or call +44 1624 672777