Manager Technical Product Management (m/w)
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We are seeking an experienced Manger who can evolve our Pharmacovigilance (PV) technology landscape, with a strong focus on case processing systems and operational excellence.
This role will partner closely with Safety, Regulatory, and IT teams to drive innovation, scale, and compliance across global PV platforms. The ideal candidate brings deep expertise in ICSR case processing workflows and hands-on experience with ArisGlobal LifeSphere MultiVigilance (LSMV), ReporterX, XDI, and RxLogix (RxL).
Key Responsibilities
-Own and execute the product roadmap for Pharmacovigilance (PV) case processing and safety platforms, translating business needs into scalable, compliant technology solutions
-Lead Agile delivery by prioritizing backlog and driving end-to-end product lifecycle, including design, validation, and releases
-Oversee end-to-end ICSR case processing capabilities (intake through regulatory submission), ensuring efficiency, quality, and compliance
-Serve as product/IT lead for ArisGlobal LSMV, and manage ReporterX and XDI for intelligent data intake and integration (E2B, structured and unstructured sources)
-Enable seamless integration with RxLogix (RxL) to support signal detection, reporting, and analytics
-Drive adoption of automation and AI to reduce manual effort, improve data quality, and enhance throughput
-Ensure compliance with global PV regulations (FDA, EMA, ICH E2B, GVP) and maintain audit/inspection readiness
-Monitor system performance, SLAs, and data quality KPIs; lead issue resolution, risk mitigation, and continuous improvement initiatives
-Act as primary interface between IT and Pharmacovigilance business teams, aligning on priorities and delivery plans
-Partner with vendors (e.g., ArisGlobal, RxLogix) on product strategy, upgrades, and innovation
-Optimize cost, vendor performance, and system utilization
-Lead and develop a high-performing team, driving performance management, coaching, and a culture of accountability and continuous improvement
Required Qualifications
-Bachelor’s degree in Information Technology, Life Sciences, or related field
-5–8+ years of experience in product management or IT application ownership in Pharmacovigilance
Hands-on experience with:
-ArisGlobal LifeSphere MultiVigilance (LSMV)
-ReporterX and XDI (data intake/integration frameworks)
-RxLogix (RxL) platform (signal detection/reporting/analytics)
-Strong understanding of ICSR case processing lifecycle and PV compliance requirements
-Experience working in GxP-regulated environments
-Exposure to Agile methodologies and modern technologies (AI/automation/data platforms)
-Excellent communication, leadership, and stakeholder management skills
Preferred Qualifications
-Experience leading global PV platform transformations or migrations
-Familiarity with regulatory inspections and audit support
-Knowledge of emerging technologies in AI-driven case processing and signal detection
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