ksb-d08-k0046

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:

1. Demonstrate L4 proficiency in ai accountability frameworks in pv
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. 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

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