Job Description

Target Pay Rate: 42.25/hr **salary will be commensurate with experience 

Job Description:

We are 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 client 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.

Job Tags

Contract work,

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