| 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
Regulatory References
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
