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

Job description

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. 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, IT, QA and Regulatory teams, and post-go-live hypercare support. Qualifications Bachelor’s or master’s degree in Life Sciences, Biotech, Pharmacy, Nursing, or related field. 8-12 years of experience with pharmacovigilance systems with handson exposure to Argus Safety configuration and validation. Strong understanding of pharmacovigilance processes, adverse event reporting requirements, and regulatory timelines. Experience working in consulting or global delivery models supporting regulated life sciences clients Knowledge of global drug safety regulations including, but not limited to FDA, EMA, ICH guidelines. Ability to work independently and as part of a team in a fast-paced, regulated environment. Strong communication skills to interact effectively with internal teams and external stakeholders. Proficiency for dashboards to communicate and understand relevant data to Business. Willingness to work flexible hours or shifts if required. Must-Have Skills And Attributes Advanced Oracle Argus Safety 8.x and above configuration experience, including product, license, study and workflow setup. Hands-on experience in case intake and processing for spontaneous, literature and clinical trial cases, with working knowledge of Argus Console, Argus Web and Argus J. Strong experience in E2B R2/R3 reporting configuration, gateway setup, submission tracking, and Argus Business Adapter configuration. Proficiency in SQL and PL/SQL, custom report development using BI Publisher or OBIEE, and data migration and reconciliation. Strong understanding of end-to-end pharmacovigilance case lifecycle management, ICSR and aggregate reporting, and global regulations including ICH E2B(R3), EU GVP and 21 CFR Part 11. Experience in computer system validation, risk-based validation, audit readiness and data integrity, including validation documentation support. Experience in new Argus implementations, workflow automation, compliance monitoring, version upgrade impact assessment and performance optimization. Hands-on experience in SIT, UAT and regression testing, including test script preparation, defect tracking and validation support. Experience in MedDRA and WHO Drug dictionary configuration, maintenance and up-versioning. Good-to-Have Skills And Attributes Experience working with Japanese clients or familiarity with PMDA reporting requirements would be an advantage. Broader knowledge of pharmacovigilance workflows, regulatory reporting processes and safety operations is preferred. Exposure to safety database implementation, test support or release deployment activities would be beneficial. Certification in pharmacovigilance, drug safety or relevant life sciences quality domains would be a plus. Exposure to GxP system documentation, validation deliverables and audit support activities would be advantageous. What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from startups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories.