ksb-d12-k0041

name: "KSB-D12-K0041" description: "AI Governance Framework Design Principles: Comprehensive understanding of AI governance framework design for pharmacovigilance organizations in..." version: "1.0.0" domain: "D12" domain_name: "Industry & Regulatory" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain ai governance framework design principles" - "what is ai governance framework design principles" - "evaluate ai governance framework design principles" epa_mapping: "EPA-06, EPA-09, EPA-16" cpa_mapping: "CPA-04" regulatory_refs: ""

KSB-D12-K0041: AI Governance Framework Design Principles

Overview

Domain: D12 - Industry & Regulatory Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate

Description

Comprehensive understanding of AI governance framework design for pharmacovigilance organizations including CIOMS WG XIV governance recommendations, organizational structure requirements, role definitions (AI Committee, QPPV responsibilities, data steward functions), policy development approaches, and integration with existing pharmacovigilance system master files. Knowledge of governance maturity models and implementation roadmaps.

Context

• Major Section: AI Governance and Regulatory Compliance
• Section: CIOMS WG XIV AI Governance Framework

EPA Mapping

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in ai governance framework design principles
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Comprehensive understanding of AI governance framework design for pharmacovigilance organizations including CIOMS WG XIV governance recommendations, organizational structure requirements, role definitions (AI Committee, QPPV responsibilities, data steward functions), policy development approaches, and integration with existing pharmacovigilance system master files. Knowledge of governance maturity models and implementation roadmaps.

Assessment Criteria

• Can evaluate core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D12 skills in CIOMS WG XIV AI Governance Framework
• Cross-domain integrations per DAG architecture

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