Pharmacovigilance Expert
Core
Authoring and reviewing drug safety reports (DSURs, PSURs/PBRERs) to train AI systems for pharmacovigilance.
Role type
Contractor Pharmacovigilance Expert
Builds
AI-driven tools for pharmacovigilance documentation and analysis
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models
Required skills
DSUR/PSUR/PBRER authoring and review, ICH E2F/E2C compliance, MedDRA coding, signal evaluation, benefit-risk assessment, aggregate safety data analysis, case-level record reconciliation
Preferred skills
QPPV or deputy QPPV experience, safety committee participation, AI-assisted safety review tool usage
Technologies
MedDRA, ICH E2F, ICH E2C(R2), GVP guidelines
Responsibilities
Author and review evaluation tasks based on safety reports; Assess accuracy of interval safety findings and signal evaluations; Reconcile figures and case counts across report sections; Evaluate safety conclusions in light of new data; Deliver structured feedback to inform AI tool development