Contractor - Global Drug Safety & PV Compliance AssociateJoulé • Plainsboro, New Jersey, US
Contractor - Global Drug Safety & PV Compliance Associate
Joulé • Plainsboro, New Jersey, US
2 days ago
Job type
- Full-time
Job descriptionActively 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. 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. 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. 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.
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
Submit your CV and any additional required information after you have read this description by clicking on the application button.
- 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
Documentation Governance
Systems and Workflow Operations
Cross-Team Support & Collaboration Serve as back-up support for Compliance Associates and assist in core departmental functions such as :
Ref : #568-Clinical
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Safety Compliance • Plainsboro, New Jersey, US
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