Contractor - Associate Director, Global Drug Safety & PV Systems Management
Joulé, Plainsboro, New Jersey, United States
Job Title: Contractor - Associate Director, Global Drug Safety & PV Systems Management
Location: Plainsboro, New Jersey
Type: Contract
Contractor Work Model: Hybrid
Schedule:
Hybrid, Mon–Fri, 9:00 AM–5:00 PM (40 hrs/week)
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.
Key Responsibilities
We are 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).
Ensure 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.
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.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #568-Clinical
#J-18808-Ljbffr
Location: Plainsboro, New Jersey
Type: Contract
Contractor Work Model: Hybrid
Schedule:
Hybrid, Mon–Fri, 9:00 AM–5:00 PM (40 hrs/week)
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.
Key Responsibilities
We are 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).
Ensure 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.
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.
System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #568-Clinical
#J-18808-Ljbffr