Pharmacovigilance
Drug safety monitoring, case processing and reporting.
- Self-paced
- 8–10 weeks
- 25+ hrs
- Credential included
Curriculum
6 subjects · 12 chapters · 48 topics
- 01
Foundations
1.1 Introduction
- What pharmacovigilance is and why it exists
- Thalidomide and the birth of drug safety
- Key definitions: AE, ADR, SAE
- Stakeholders in drug safety
1.2 Drug development context
- Phases of clinical trials
- Pre-clinical safety
- Post-marketing surveillance
- Benefit-risk thinking
- 02
Adverse Events
2.1 Case identification
- Sources of individual case safety reports
- Valid case criteria
- Solicited and spontaneous reports
- Literature and social media sources
2.2 Case processing
- Data entry and coding
- MedDRA terminology
- WHO-DD drug dictionary
- Narrative writing
2.3 Assessment
- Seriousness criteria
- Expectedness and reference safety information
- Causality assessment methods
- Severity versus seriousness
- 03
Regulation and Reporting
3.1 Regulatory framework
- ICH guidelines E2A to E2F
- CDSCO and Indian requirements
- FDA and EMA requirements
- Good pharmacovigilance practices
3.2 Reporting obligations
- Expedited reporting timelines
- Periodic safety update reports
- Development safety update reports
- Regulatory submissions and gateways
- 04
Signal Management and Risk
4.1 Signal detection
- Data mining and disproportionality
- Signal validation and prioritisation
- Signal evaluation
- Documentation of signals
4.2 Risk management
- Risk management plans
- Risk minimisation measures
- Effectiveness evaluation
- Labelling updates
- 05
Systems and Quality
5.1 Safety databases
- Argus and ARISg overview
- Workflow and case lifecycle
- Data quality checks
- Reconciliation
5.2 Quality and inspection
- Standard operating procedures
- Audits and inspections
- CAPA
- Pharmacovigilance system master file
- 06
Practice
6.1 Applied work
- Processing sample cases end to end
- Writing a narrative
- Preparing a periodic report section
- Career paths in drug safety
