Head of Pharmacovigilance
Core
Lead the in-house pharmacovigilance function across clinical development and commercial products, owning the safety system, team, and final medical safety decisions. (via careerplan.io/jobs/5439689008-head-of-pharmacovigilance-at-praxisprecisionmedicines)
Role type
Senior leadership physician (Head of Pharmacovigilance)
Builds
In-house pharmacovigilance system, safety database, and operational model for clinical and postmarketing safety
Domain
Life Sciences / Pharmacovigilance / Regulatory Safety
Required skills
Pharmacovigilance operations, benefit-risk assessment, signal adjudication, regulatory reporting compliance, team leadership, quality system design, AI governance
Preferred skills
Experience with AI-enabled safety systems, in-house PV function setup
Technologies
AI-enabled safety database, validated safety systems
Responsibilities
Lead the PV function and team; make final medical determinations on benefit-risk and signal causality; ensure regulatory reporting compliance; design the PV operating model and quality system; chair the Signal Management Committee; lead interactions with health authorities.
Seniority
Executive, hands-on IC