Adverse Event and Pharmacovigilance
Adverse event cycle: report, severity triage, patient safety measures, investigation, root cause, action plan and closure for the periodic report. Built for operations teams, structured execution with approval gates and an audit trail.
For: Reporter, Pharmacovigilance Officer, Physician, Quality Manager, and Safety Committee teams running adverse event and pharmacovigilance
What this template includes
Process steps
- 1Report the event
- 2Initial triage and severity classification
- 3Immediate patient safety measures
- 4Investigate the event
- 5Root cause analysis
- 6Checkpoint 1, Review by the safety committee
- 7Action plan
- 8Notify the health authority when applicable
- 9Close and include in the periodic report
Why teams use this template
Adverse event cycle: report, severity triage, patient safety measures, investigation, root cause, action plan and closure for the periodic report. When this work runs through inboxes and ad-hoc spreadsheets, ownership gets fuzzy and evidence gets lost. Adverse Event and Pharmacovigilance gives you a 9-step process with 1 checkpoint so nothing slips between handoffs.
Built for teams led by Reporter, Pharmacovigilance Officer, Physician, Quality Manager, and Safety Committee: every task has a named owner, every approval routes to a real role, and the run history is the audit trail your auditors actually want.
The checkpoint tasks ("Checkpoint 1, Review by the safety committee") cannot be skipped, they're where the run produces evidence the next stage depends on. You start with structure instead of building it from scratch every time.
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