By name: "KSB-D01-K0055" description: "PV AI Governance Frameworks: Understanding of governance structures required for AI in pharmacovigilance including organizational..." version: "1.0.0" domain: "D01" domain_name: "Foundations of Pharmacovigilance" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain pv ai governance frameworks" - "what is pv ai governance frameworks" - "apply pv ai governance frameworks" epa_mapping: "EPA-01, EPA-10" cpa_mapping: "CPA-01" regulatory_refs: ""
KSB-D01-K0055: PV AI Governance Frameworks
Overview
Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Understanding of governance structures required for AI in pharmacovigilance including organizational accountability models, AI system inventory management, model risk management principles, and regulatory compliance frameworks for AI oversight in drug safety operations.
Context
- Major Section: AI-Era Pharmacovigilance Foundations
- Section: AI Governance Fundamentals
EPA Mapping
- EPA-01:3001-3003
- EPA-10:3023-3024
CPA Pathway
- CPA-01
Regulatory References
- General PV competency
Instructions
When this skill is activated, Claude should:
- Demonstrate L3 proficiency in pv ai governance frameworks
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-01, EPA-10
Key Competencies
- Understanding of governance structures required for AI in pharmacovigilance including organizational accountability models, AI system inventory management, model risk management principles, and regulatory compliance frameworks for AI oversight in drug safety operations.
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D01 skills in AI Governance Fundamentals
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31