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
Job Description Why You Want To Work Here: We represent a growing union providing our members with competitive benefits and powerful resources to help advance their careers. We have a casual and fun environment and opportunity for advancement! The Recipient Services...
...Our client, an American multinational pharmaceutical, biotech, and medical technology corporation, is actively looking for a Change Manager to join their team in New Brunswick, NJ! This role can be remote however they're ideally looking for someone who has the...
...development and TrialStage. Improve technical tasks and project targets from a technical viewpoint for product design. Lead entry level engineers through mentorship. Key Accountabilities Conduct studies and detailed confirmations of new technologies, design...
...Job Description GHR Healthcare is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Saratoga Springs, New... ...communication, and a devoted team that genuinely cares about your career journey. You can trust us to stand by your side...
...strategy, and goals of the assigned academic entity/program(s). Ideal candidateswill **have expertise in designing and conducting epidemiological studies,** and will be an enthusiastic, resourceful, proactive, bright, organized, and collaborative.Candidates should have a...