Job Opportunity: Pharmacovigilance Manager
We are seeking a talented and experienced Manager to enhance our Pharmacovigilance (PV) technology landscape, with a strong emphasis on case processing systems and operational excellence.
This role will involve close collaboration with Safety, Regulatory, and IT teams to drive innovation, scalability, and compliance across global PV platforms. The ideal candidate will possess deep expertise in ICSR case processing workflows and significant 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 the backlog and driving the end-to-end product lifecycle, including design, validation, and releases.
- Oversee end-to-end ICSR case processing capabilities, ensuring efficiency, quality, and compliance from intake through regulatory submission.
- Serve as the product/IT lead for ArisGlobal LSMV, while managing ReporterX and XDI for intelligent data intake and integration (including E2B and both structured and unstructured sources).
- Enable seamless integration with RxLogix (RxL) to support signal detection, reporting, and analytics.
- Drive the 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, leading issue resolution, risk mitigation, and continuous improvement initiatives.
- Act as the 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 fostering a culture of accountability and continuous improvement.
Required Qualifications
- Bachelor’s degree in Information Technology, Life Sciences, or a related field.
- 5 to 8+ years of experience in product management or IT application ownership in Pharmacovigilance.
- Hands-on experience with ArisGlobal LifeSphere MultiVigilance (LSMV), ReporterX, and XDI.
- Experience with the RxLogix (RxL) platform for signal detection, reporting, and analytics.
- Strong understanding of the ICSR case processing lifecycle and PV compliance requirements.
- Experience in GxP-regulated environments.
- Exposure to Agile methodologies and modern technologies including AI, automation, and 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.
Apply online using the form below. Please note that only applications matching the job profile will be considered.