Table 1.

Scope of PV domain-facing activities in the context of knowledge bases and skill sets needed to support these activities.

Domain-Facing Activity	Knowledge Bases and Skill Sets
	Content-Focused: Subject Matter Experts	Process-Focused: Operational Experts
Core PV Disciplines
Case management	Analytical, medical	Project management database management
Signal management	Systems analysis, medical, TSA, social media	Data management, social media
Benefit-risk management	Risk: concepts, analysis, communication	Risk: communication, project management
Other PV Domain-Facing Disciplines
Animal pharmacology	Animal physiology: adverse event profiles, PK/PD properties	Project management
Clinical pharmacology	Human physiology: adverse event profiles, PK/PD properties	Project management
Regulatory/labeling	Global regulatory structures, risk communication, negotiation	Regulations, risk communication
Clinical trials	Bioethics: consent, IRB, DMC, trial design
Manufacturing	Manufacturing process; quality: FMEA; SPC; security
Database management	Software, artificial intelligence
Epidemiology/biostatistics	Quantitative methods (including analytics)
Medical affairs	Communication

DMC = data monitoring committee; FMEA = failure mode effects analysis; IRB = institutional review board; PK/PD = pharmacokinetic/pharmacodynamic; PV = pharmacovigilance; SPC = statistical process controls; TSA = time series analysis.