Pharmacovigilance and Drug Safety Evaluation
Job Description
Evaluate aggregate safety reports and associated case evidence. Check interval and cumulative figures, signal analysis, report structure and benefit-risk conclusions, reconcile discrepancies and provide reasoned judgments that can be independently reviewed.
Professional background
Preferred contributors have at least five years in drug safety/pharmacovigilance and end-to-end DSUR or PSUR/PBRER authorship or review. Bring ICH E2F, E2C(R2) and GVP knowledge, signal and benefit–risk analysis, MedDRA, case seriousness/causality/expectedness assessment and reconciliation of individual cases with aggregate results.
An advanced relevant degree in clinical or life sciences, pharmacy or nursing is preferred. Development and postmarketing breadth, QPPV/deputy responsibilities, safety-committee participation and AI-assisted review experience are advantages.
Working arrangements
This is remote, paid IXO expert work. Agree the specific task brief, permitted materials, outputs and working schedule with IXO before starting. Any commitment or duration described in a practice profile is an indicative planning requirement for that route, subject to that agreement.
Pay
$80 • $140/hr USD. The applicable rate is agreed for the work and professional track before you begin.
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