Seeking an experienced contractor to support Oracle Argus Safety System Management activities with a focus on: - Triage and quality review of Argus configuration/change requests, ensuring completeness, accuracy, and testability - Strategic User Acceptance Testing (UAT) in Argus, including test planning, execution, defect management, and inspection-ready documentation - Strong knowledge of ICH E2B(R2) and E2B(R3) conventions and practical experience supporting ICSR reporting/submissions (FDA/EMA and global) This role is critical to ensuring that Argus changes and enhancements perform as intended, meet regulatory requirements and business needs, and are supported by high-quality, inspection-ready testing evidence and end-to-end traceability.

Key Responsibilities:

- Triage Argus configuration/change requests, validating that required information is provided.

- Partner with requestors, internal Argus administrators, and/or system vendor(s) to clarify requirements, confirm feasibility, and finalize scope for configuration and customization changes.

- Develop and execute a risk-based UAT approach to validate that configuration/customization changes meet the requested business and/or regulatory outcomes, and do not negatively impact existing system functionality (appropriate regression testing).

- Create and maintain audit/inspection-ready UAT deliverables, including test scripts/scenarios, executed evidence, defect logs, retest documentation, and UAT summary/sign-off as applicable.

- Communicate testing progress, issues, and risks clearly to stakeholders; escalate quality/compliance concerns promptly.

- Participate in safety application projects (e.g., implement or upgrade) as a business SME and author or review user documents including user requirement specifications and UAT scripts.

Required Qualifications:

- Strong hands-on Oracle Argus Safety experience in system configuration and/or administration, including UAT planning and execution.

- Demonstrated expertise with ICH E2B(R2) and ICH E2B(R3) requirements and conventions.

- Practical experience with safety case processing and ICSR submissions/reporting.

- Strong knowledge of PV regulations/guidance impacting case collection, processing, and submissions (e.g., FDA CFR, ICH, EU GVP, etc.).

- Proven ability to produce high-quality UAT documentation suitable for audits/inspections (traceable, complete, and well-organized).

- Excellent stakeholder management and communication skills, with the ability to translate business needs into testable system behavior.