Safety Argus Testing Consultant - AI & Engineering
- Serve as the onsite testing lead 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.
- 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.
- Ability to work independently and collaborate as part of a team
- Effective written and verbal communication skills
- Meticulous attention to detail and quality of work product
- Ability to build and sustain professional relationships
- Ability to lead projects or workstreams
- Ability to manage and prioritize multiple tasks in a fast-paced and dynamic environment
- Strong interpersonal skills and professional demeanor
- Ability to meet deadlines
- Ability to provide clear guidance to others
- 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
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