Pharmacovigilance training includes:

 
Part I  - Hands on case processing of safety reports in a work-based scenario
Part II - Advanced training in Pharmacovigilance
Serious Adverse Events (SAEs)
  • Case receipt and acknowledgement
  • Validity checks
  • Duplicate checks 
  • Triage
  • Narratives writing
  • Data entry into safety database
  • MedDRA coding
  • Quality Control (QC)
  • Query generation, management and due diligence
  • Tracking 
  • Electronic and TMF filing

Expedited Reporting
  • Generation of CIOMs
  • Blinding/unblinding reports as required for safety reasons
  • Suspected unexpected serious adverse reaction (SUSAR) submissions 
  • Periodic Safety Reports (PSR) submissions
  • Urgent Safety Measures Reporting
Technical Writing (Part II)
  • Writing: Development Safety Update Report (DSUR)
  • Writing: Periodic Safety Update Report (PSUR)
  • Writing: Six-monthly Safety Report (SSR)
  • Data Review and Analysis 
  • Standard Operating Procedure (SOP)
  • Safety Management Plan (SMP)
  • Writing: Safety Data Exchange Agreement (SDEA)
  • Pharmacovigilance Agreements (PVA)

Part II continued
  • Signal detection in clinical trials
  • Signal evaluation
  • Signal validation
  • Management of validated signals and signal tracking
  • Literature Review