Project Engineer (Life Sciences)

agap2 - HIQ Consulting; Basel; Hybrid; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Stakeholder management

Leadership

Agile methodologies

Communication

Ausbildung

Bachelor’s degree in IT or Life Sciences

Tools

ArisGlobal LifeSphere LSMV

ReporterX

XDI

RxLogix (RxL)

Jobbeschreibung

Location: Basel Region, Switzerland (Hybrid).We are supporting a globally recognised organisation that develops advanced solutions used by industries worldwide.With a strong focus on innovation, su

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 ( , 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