Pharmacovigilance

Pharmacovigilance (PV) is the science connected to the monitoring, assessment, detection, understanding and prevention of unrecognised adverse effects or changes in the patterns of adverse effects in medicines. PV aims to enhance patient care and patient safety in relation to the use of medicines; and to support public health by providing reliable information for the effective assessment of the benefit-risk profile of medicines.

Here at Panacea, we provide a full suite of PV services, including:

  • 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.
    • 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

Medical Information

Panacea also offer of a 24/7 medical information service to the UK and Ireland.