Contractor - Global Drug Safety & PV Compliance Associate
System One
Title: Global Drug Safety and PV Compliance Associate
Location: Must be local for hybrid schedule in Princeton area
Rate: Up to $42/hour (dependent on experience)
Term: 1-year renewable contract
Qualifications: Hybrid Schedule - will work with team to ensure at least 1 team member is onsite at any time. Flexibility.
Pharma company seeking an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and Pharmacovigilance (GDS&PV) Department. The ideal candidate will possess a methodical approach to task prioritization, particularly when handling multiple assignments, must demonstrate strong documentation governance, inspection readiness, and cross-functional collaboration across our global safety network.
Key Responsibilities
Inspection & Audit Readiness
- Actively participate in (un)announced inspections and (partner) audits conducted at the US site.
- Ensure real-time support and documentation retrieval during inspections/audits, working closely with global safety teams.
- Lead or support logistics and preparation of inspection rooms, document coordination, quality control and documentation tracking, oversight of agenda and deliverables.
- Maintain inspection readiness at all times by routinely overseeing critical documentation areas and ensuring compliance with internal and external standards.
Documentation Governance
- Manage the filing, oversight, and retrieval of safety trial documentation within the Veeva Vault Clinical (eTMF), Quality and RIMS
- Conduct quality control reviews and ensure adherence to internal naming conventions, indexing standards, and document metadata requirements.
- Oversee proper document numbering and traceability, and maintain real-time overviews of uploaded safety documentation.
Systems and Workflow Operations
- Upload and maintain safety and compliance documents in Veeva Vault modules.
- Monitor, triage, and assign items from shared mailboxes, ensuring smooth team operations.
- Administer and maintain SharePoint sites and shared resources for the GDS&PV Compliance Team.
- Guide record retention practices and ensure alignment with company and regulatory standards.
Cross-Team Support & Collaboration
Serve as back-up support for Compliance Associates and assist in core departmental functions such as:
- Training Assignments and compliance in Veeva Vault
- GCP/GxP procedure distribution (internal and external)
- Coordination and support of compliance meetings (agenda, slides, follow-up)
- Safety vendor onboarding and access provisioning in Vault
- Liaise with Safety Scientists, QA, Clinical, and Regulatory Affairs to ensure cohesive documentation and process alignment.
Ref: #568-Clinical
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.
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