Post-Marketing Safety Reporting (PMS)

PMS is the process of monitoring the safety of a pharmaceutical drug, device or vaccine. It confirms the safety of the drug after it is used in a large number of population.

PvEdge offers an analysis of adverse events arising from the use of pharmaceutical products in general populations. Below are the features provided by application:

  • Provides a quick overview facilitating faster-informed decisions
  • Alerts for pending cases facilitates easy task management
  • Dashboard includes: Notice board, Workflow efficiency, PSUR–PADER alerts, Follow-up alerts, Expedited and Non-expedited alerts facilitating timely informed decisions ensuring compliance with the legal requirements for pharmacovigilance tasks and responsibilities.
  • Workflow efficiency helps to identify bottlenecks and manages even distribution of work
  • Follow-up alerts help track all follow-ups and set reminders according to in-built escalation rules until case closure
  • Country Inbox facilitates auto scheduling of reports based on in-built regulatory submission rules
  • Alerts for PSUR-PADER reports submission ensures aggregate report compliance
  • Integrated Outlook mailing facility for appropriate timely actions