Pharmacovigilance Platform Lead—Case Processing
agap2 - HIQ Consulting
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Job summary
agap2 - HIQ Consulting seeks an experienced Product Manager for Pharmacovigilance to lead PV case processing and safety platforms. You will partner with Safety, Regulatory and IT to drive scalable, compliant technology solutions.
The role focuses on LSMV, ReporterX, XDI, and RxLogix integrations, with strong emphasis on Agile delivery, data quality, and automation to enable global PV operations.
Qualifications
- Bachelor’s degree in IT, Life Sciences, or related field.
- 5–8+ years in product management or IT ownership in Pharmacovigilance.
- Hands‑on with ArisGlobal LifeSphere MultiVigilance (LSMV).
- Experience with ReporterX and XDI data intake/integration.
- Experience with RxLogix platform for signal detection and analytics.
- Strong knowledge of ICSR lifecycle and PV compliance.
- Experience in GxP environments and Agile environments.
Responsibilities
- Own and execute the PV case processing and safety platform roadmap.
- Lead Agile delivery, prioritize backlog and drive end-to-end lifecycle.
- Oversee ICSR processing from intake to regulatory submission.
- Serve as IT lead for ArisGlobal LSMV and manage ReporterX/XDI integrations.
- Enable integration with RxLogix to support signal detection and analytics.
- Drive automation and AI to improve data quality and throughput.
- Ensure compliance with FDA/EMA/ICH/GVP and audit readiness.
- Monitor SLAs, data quality KPIs, and drive continuous improvement.
- Act as primary IT interface to PV business teams; align priorities.
- Collaborate with vendors on strategy, upgrades, and innovation.
Skills
Education
Tools
Job description
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