GPV Functional QA Sr. Consultant

Work you’ll do/Responsibilities

• Lead the onsite testing lead for Global Pharmacovigilance (GPV) tower — a 16-application portfolio covering the full PV case lifecycle from adverse event intake through signal detection and aggregate reporting.
• Understand the pharmacovigilance data flow and be comfortable leading client-facing interactions, driving UAT coordination, and ensuring release readiness in a GxP-regulated environment with zero-defect tolerance.
• Develop and execute test strategy and plans for GxP-regulated PV applications in alignment with CSA/CSV methodology and Functional Risk Assessment (FRA) outcomes.
• Design and execute test scenarios across SIT, UAT, OQ, and PQ phases for safety database (AVISSO), signal detection (Empirica), intake (Global Intake Tool), coding (MedDRA), and reporting systems (ICSR Rules, SLARDS).
• Lead UAT coordination — scheduling, entry/exit criteria, business SME participation, and timely sign-off.
• Own defect lifecycle management including triage, root cause discussion, stakeholder communication, and closure.
• Prepare and present testing status reports, defect dashboards, and release readiness assessments to client stakeholders.
• Proactively escalate testing risks and issues with clear ownership and resolution timelines.
• Operate within ALM/ALVIS for test planning, execution tracking, and evidence capture.

Qualifications Required

• 5+ years of onsite testing for the GPV tower, acting as the primary interface between the testing team and GPV business stakeholders, project managers, and release governance forums.
• Develop and execute test strategy and plans for GxP-regulated PV applications in alignment with CSA/CSV methodology and Functional Risk Assessment (FRA) outcomes.
• Design and execute test scenarios across SIT, UAT, OQ, and PQ phases for safety database (AVISSO), signal detection (Empirica), intake (Global Intake Tool), coding (MedDRA), and reporting systems (ICSR Rules, SLARDS).
• Lead UAT coordination — scheduling, entry/exit criteria, business SME participation, and timely sign-off.
• Operate within ALM/ALVIS for test planning, execution tracking, and evidence capture.
• Bachelor’s degree, preferably in information technology, business, or healthcare related field; or equivalent experience.
• Limited immigration sponsorship may be available.
• Ability to travel 10%, on average, based on the work you do and the clients and industries/sectors you serve.