Contractor - Global Drug Safety & PV Compliance Associate

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