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

EY GDS Consulting Enterprise Risk (ER) Regulatory Compliance Manager Argus Safety Configuration Specialist

At EY were all in to shape your future with confidence.

Well 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 line with our commitment to quality youll 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 EYs 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 endtoend 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 endtoend Oracle Argus Safety implementations upgrades and global rollouts
• Own advanced system configuration customization validation and governance
• Ensure compliance with global PV regulations andGxPrequirements
• 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

• Bachelors or masters 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 were 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 thats right for you