Training
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
