PV Tech Platform Lead | AI-Driven Case Processing

8542-Actelion Pharmaceuticals Ltd Legal Entity; Allschwil; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

Johnson & Johnson in Allschwil, Basel-Country, Switzerland seeks an experienced Product Manager to evolve the Pharmacovigilance tech landscape, with a strong focus on case processing systems and operational excellence.

The role partners with Safety, Regulatory, and IT to drive innovation, scale, and PV compliance across global platforms. Deep expertise in ICSR workflows and LSMV, ReporterX, XDI, RxLogix is required.

Qualifikationen

• 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.

Aufgaben

• 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.

Ausbildung

Bachelor’s degree in Information Technology, Life Sciences, or related field

Tools

ArisGlobal LifeSphere MultiVigilance (LSMV)

ReporterX

XDI

RxLogix (RxL)

Jobbeschreibung

Johnson & Johnson in Allschwil, Basel-Country, Switzerland seeks an experienced Product Manager to evolve the Pharmacovigilance tech landscape, with a strong focus on case processing systems and operational excellence.

The role partners with Safety, Regulatory, and IT to drive innovation, scale, and PV compliance across global platforms. Deep expertise in ICSR workflows and LSMV, ReporterX, XDI, RxLogix is required.