Pharmacovigilance – Drug Safety Services

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
  • 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