Contractor - Associate Director, Global Drug Safety & PV Systems Management
System One, Plainsboro, New Jersey, United States
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.
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).
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 does not provide traditional employee benefits to contractors, but eligible employees receive health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and 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.
Reference #568-Clinical
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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.
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).
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 does not provide traditional employee benefits to contractors, but eligible employees receive health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, and 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.
Reference #568-Clinical
#J-18808-Ljbffr