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