Oversee global case management activities across one or multiple pharmacovigilance platforms
Monitor performance indicators (KPIs) and report them to Safety leads and Quality teams
Provide operational on-the-ground support: quality review of cases, issue resolution, and daily team coaching/support
Manage case processing and transmission timelines in compliance with regulatory and contractual requirements
Coordinate and oversee external vendors (case processing, literature screening)
Ensure case reconciliation with partners and clinical databases (SDEA/PVA)
Contribute to management of CAPAs, audits, inspections, and quality documentation related to case processing
Collaborate with PV tools teams to implement regulatory intelligence updates into safety databases

Bachelor's degree (BSc) or equivalent in life sciences (minimum)
Minimum 7 years' experience in pharmacovigilance
Proficiency with safety databases (Argus Safety or equivalent)
Strong MedDRA coding skills, narrative writing, and data quality control
Experience managing outsourced activities and coordinating vendors
Experience tracking KPIs, handling deviations, CAPA, audits, and inspections
Familiarity with international regulations (EMA, FDA, MHRA, PMDA, Health Canada)
PV guidelines: ICH E2B, GVP, CIOMS
Autonomous, proactive, and able to manage multiple priorities
Professional-level English required (written and spoken)

Consultant – Pharmacovigilance Case Processing Officer

About this role