ksb-d01-k0055

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:

1. Demonstrate L3 proficiency in pv ai governance frameworks
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. 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

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Generated from PV KSB Framework v1.0 | 2025-12-31