RC-REGULATORY COMPLIANCE-PV-CA-Argus-Manager

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Join EY and help to build a better working world.

EY – GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance – Manager– Argus Safety – Configuration Specialist At EY, we’re all in to shape your future with confidence.    We’ll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go.  Join EY and help to build a better working world.   As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance Senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.   The opportunity This role offers the opportunity to work on global pharmacovigilance technology and regulatory compliance transformation programs across multiple jurisdictions. You will support clients in strengthening patient safety, inspection readiness, and system governance, directly contributing to EY’s purpose of Building a better working world.   Role Overview As an Argus Safety Configuration Specialist, you will be responsible for configuring, validating, and governing Argus Safety solutions to support end‑to‑end pharmacovigilance processes, ensuring alignment with global regulatory expectations and client SOPs.   Your key responsibilities Client Responsibilities

Lead end-to-end Oracle Argus Safety configuration, enhancement and upgrade activities across Lead end‑to‑end Oracle Argus Safety implementations, upgrades, and global rollouts  Own advanced system configuration, customization, validation, and governance  Ensure compliance with global PV regulations and GxP requirements  Lead integrations, data migrations, testing, and inspection readiness  Manage project teams and senior client stakeholders  Mentor junior team members and contribute to EY internal initiatives.

Skills and attributes for success

Advanced configuration expertise in Oracle Argus Safety 8.x and above, including product, license, study and workflow setup. Hands-on experience in case intake and processing workflows across spontaneous, literature and clinical trial cases, with working knowledge of Argus Console, Argus Web and Argus J modules. Strong capability in E2B R2/R3 reporting configuration, gateway setup, submission tracking, and Argus Business Adapter configuration to enable compliant external integrations. Proficiency in advanced SQL and PL/SQL, custom report development using BI Publisher or OBIEE, and data migration or reconciliation activities. Strong understanding of end-to-end pharmacovigilance case lifecycle management, ICSR and aggregate reporting, and applicable regulatory standards including ICH E2B(R3), EU GVP and 21 CFR Part 11. Experience in computer system validation, risk-based validation, audit readiness and data integrity practices, including support for compliant validation documentation. Experience supporting new Argus implementations, workflow automation, SLA and compliance monitoring, legacy data migration, version upgrade impact assessment and performance optimization. Demonstrated ability to lead SIT, UAT and regression testing activities, including test strategy, script design, defect management and release readiness support. Strong consulting and project delivery skills, including client requirements gathering, solution design, stakeholder management across PV,