By name: "KSB-D08-K0046" description: "AI Accountability Frameworks in PV: Knowledge of accountability structures for AI-driven pharmacovigilance decisions including role-base..." version: "1.0.0" domain: "D08" domain_name: "Signal Detection & Management" type: "Knowledge" proficiency_level: "L4" bloom_level: "evaluate" triggers: - "explain ai accountability frameworks in pv" - "what is ai accountability frameworks in pv" - "evaluate ai accountability frameworks in pv" epa_mapping: "EPA-04, EPA-05" cpa_mapping: "CPA-02" regulatory_refs: ""
KSB-D08-K0046: AI Accountability Frameworks in PV
Overview
Domain: D08 - Signal Detection & Management Type: Knowledge Proficiency Level: L4 (Proficient - Independent practice) Bloom Level: Evaluate
Description
Knowledge of accountability structures for AI-driven pharmacovigilance decisions including role-based responsibility assignment, decision audit trails, liability considerations for AI-assisted safety assessments, organizational accountability hierarchies, and documentation requirements for demonstrating human oversight. Understanding of shared accountability models between AI systems and human reviewers per CIOMS WG XIV Chapter 4 and Chapter 9 governance principles.
Context
- Major Section: AI Integration and Advanced Analytics
- Section: Human Oversight in AI-Driven Signal Detection
EPA Mapping
- EPA-04:3009-3010
- EPA-05:3011-3012
CPA Pathway
- CPA-02
Regulatory References
- General PV competency
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in ai accountability frameworks in pv
- Apply evaluate level cognitive skills to evaluate the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-04, EPA-05
Key Competencies
- Knowledge of accountability structures for AI-driven pharmacovigilance decisions including role-based responsibility assignment, decision audit trails, liability considerations for AI-assisted safety assessments, organizational accountability hierarchies, and documentation requirements for demonstrating human oversight. Understanding of shared accountability models between AI systems and human reviewers per CIOMS WG XIV Chapter 4 and Chapter 9 governance principles.
Assessment Criteria
- Can evaluate core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D08 skills in Human Oversight in AI-Driven Signal Detection
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31