NoyMed Academy Certified Safety Specialist
Pharmacovigilance from case intake to signal detection and reporting.
About this program
Drug safety fundamentals: individual case safety reports, coding, expedited and aggregate reporting, and an introduction to signal management.
Who it is for
Nurses, pharmacists, and life-science graduates entering pharmacovigilance.
Prerequisites
- Life-sciences or healthcare background
- Strong documentation habits
- Comfort with medical terminology
Curriculum outline
1. Pharmacovigilance foundations
Concepts, regulations, and roles.
Topics: GVP modules overview · Key definitions · The QPPV · Safety data sources
2. Individual case safety reports
Processing a case.
Topics: Case intake and triage · Seriousness and expectedness · Narrative writing · MedDRA coding
3. Expedited and aggregate reporting
Meeting reporting obligations.
Topics: 15-day reports · DSUR / PBRER / PSUR · Submission gateways (E2B)
4. Signal management (introduction)
From data to action.
Topics: Signal detection basics · Disproportionality · Risk management plans
5. Quality and inspection readiness
Keeping pharmacovigilance audit-ready.
Topics: Compliance metrics · CAPA · Audit and inspection support
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