GENERAL SUMMARY:

In this role, the Senior Principal Analyst, GPS Tech Lead will partner with other DTE technical leads, business teams (PV Systems, Case Processing, PV Quality) and vendor teams to refine and execute the technology roadmap by supporting the evaluation, selection, implementation, and ongoing maintenance of new and/or upgraded Safety solutions.
Additionally, they will maintain reliable, scalable and compliant systems, ensure delivery and enhancements that provide opportunities for developing and implementing innovative solutions (including AI driven capabilities) and integrations that easily support current and evolving business needs. These systems include PV focused solutions such as Argus (Global Safety Database), Empirica (Safety Signal Detection), PV Reports, Veeva SafetyDocs, Axway E2B Gateway, Reportum as well as core technology solutions such as Amazon Web Services (AWS), ServiceNow, Toad Data Point, OBIEE and Power BI.

KNOWLEDGE AND SKILLS:

• Strong understanding of the PV business processes, drivers, and metrics (such as case processing, E2B R2/R3 and aggregate reporting, and signal detection)
• Strong understanding of GxP, safety regulations
• Understanding of Safety/PV technology landscape including AI related solutions
• Hands on experience with database/SQL and Windows platforms
• Knowledge of Signal Detection system (i.e. Empirica Signal and Topics), ArMMs
• Demonstrates a solid understanding and application of good project management practices, as well as the fundamentals of System Life Cycle (SLC) and IT operational practices.
• In-depth knowledge in the core disciplines of project management, business analysis, solution design, change management, delivery, and testing
• Experienced in building productive partnerships with business stakeholders and aligning them around a recommendation/solution
• Able to manage own workload with minimal direction
• Exceptional analytical, quantitative, problem-solving, and prioritization skills
• Experience working with IT managed services or outsourced/offshore teams

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in technology discipline or equivalent
• Typically requires 8+ years relevant business systems in the Life Sciences industry, or the equivalent combination of education and experience

• Become a trusted partner of the business teams and other DTE cross functional teams; understand their needs and deliver technology solutions to support and enable their goals and objectives
• Strategize on how technology can improve business processes to enable operating efficiencies and support the achievement of business goals and objectives including AI
• Refine and execute the technology roadmap by supporting the evaluation, selection, implementation, and ongoing maintenance of new and/or upgraded systems, including Safety Database, Reporting, Signal Detection, E2B Gateway, Safety data (Adverse events and product complaints) Intake solutions.
• Develop and maintain a long-term life cycle plan for the ongoing maintenance and management of systems
• Manage the support of existing systems to ensure business continuity and address user issues and requests; this includes administration and configuration executed and documented per Vertex procedures
• Coordinate with end users, Managed Service Providers, and DTE colleagues to resolve systems issues and advance projects, including development of materials to support end user and Managed Service Provider staff training
• Manage relationships with our strategic software vendors and service providers
• Provide updates to senior management on activities, including work done by DTE colleagues, business support team, and Managed Service Providers, for technical and validation services
• Identify and design solutions to integrate and analyze data across platforms.
• Gather and develop business requirements, workflow and data flow diagrams
• Work across Vertex to identify opportunities for process improvements, determine the user requirements, map future business capabilities to strategic outcomes, and present findings to leadership on solution proposals and recommendations