By name: "KSB-D01-K0054" description: "AI Ethics in Drug Safety: Comprehension of ethical considerations in AI-enabled pharmacovigilance including algorithmic transp..." version: "1.0.0" domain: "D01" domain_name: "Foundations of Pharmacovigilance" type: "Knowledge" proficiency_level: "L3" bloom_level: "apply" triggers: - "explain ai ethics in drug safety" - "what is ai ethics in drug safety" - "apply ai ethics in drug safety" epa_mapping: "EPA-01, EPA-10" cpa_mapping: "CPA-01" regulatory_refs: ""
KSB-D01-K0054: AI Ethics in Drug Safety
Overview
Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L3 (Competent - Minimal supervision) Bloom Level: Apply
Description
Comprehension of ethical considerations in AI-enabled pharmacovigilance including algorithmic transparency, patient data privacy in AI training, equitable AI access across regions, and responsible AI development principles. Understanding of CIOMS, FDA, and EMA ethical frameworks for AI in healthcare.
Context
- Major Section: AI-Era Pharmacovigilance Foundations
- Section: AI Transformation of PV
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:
- Demonstrate L3 proficiency in ai ethics in drug safety
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-01, EPA-10
Key Competencies
- Comprehension of ethical considerations in AI-enabled pharmacovigilance including algorithmic transparency, patient data privacy in AI training, equitable AI access across regions, and responsible AI development principles. Understanding of CIOMS, FDA, and EMA ethical frameworks for AI in healthcare.
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 Transformation of PV
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31