The role
0301Own and execute the product roadmap for Pharmacovigilance (PV) case processing and safety platforms, translating business needs into scalable, compliant technology solutions
02Lead Agile delivery by prioritizing backlog and driving end-to-end product lifecycle, including design, validation, and releases
03Oversee end-to-end ICSR case processing capabilities (intake through regulatory submission), ensuring efficiency, quality, and compliance
04Serve as product/IT lead for ArisGlobal LSMV, and manage ReporterX and XDI for intelligent data intake and integration (E2B, structured and unstructured sources)
05Enable seamless integration with RxLogix (RxL) to support signal detection, reporting, and analytics
06Drive adoption of automation and AI to reduce manual effort, improve data quality, and enhance throughput
07Ensure compliance with global PV regulations (FDA, EMA, ICH E2B, GVP) and maintain audit/inspection readiness
08Monitor system performance, SLAs, and data quality KPIs; lead issue resolution, risk mitigation, and continuous improvement initiatives
09Act as primary interface between IT and Pharmacovigilance business teams, aligning on priorities and delivery plans
10Partner with vendors (e.g., ArisGlobal, RxLogix) on product strategy, upgrades, and innovation
11Optimize cost, vendor performance, and system utilization
12Lead and develop a high-performing team, driving performance management, coaching, and a culture of accountability and continuous improvement
