Associate Director, Global Drug Safety & Pharmacovigilance Data Management
AllSTEM Connections, Plainsboro, New Jersey, United States
AllSTEM Connections is seeking an Associate Director, Global Drug Safety & Pharmacovigilance Data Management to work hybrid/onsite (1-2 days/week) in Plainsboro, NJ.
This is a
6-month contract
position. Possible extension/temp-to-hire. Hourly rate is up to
$90/hour . M-F, 8AM - 5PM. SUMMARY:
Our confidential client is 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 Client business needs, and are supported by high-quality, inspection-ready testing evidence and end-to-end traceability. 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; elevate 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. QUALIFICATIONS
Hybrid Work Schedule - must be able to report onsite 1-2 days a week 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.
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6-month contract
position. Possible extension/temp-to-hire. Hourly rate is up to
$90/hour . M-F, 8AM - 5PM. SUMMARY:
Our confidential client is 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 Client business needs, and are supported by high-quality, inspection-ready testing evidence and end-to-end traceability. 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; elevate 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. QUALIFICATIONS
Hybrid Work Schedule - must be able to report onsite 1-2 days a week 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.
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