Senior Patient Safety Vendor Management Manager

Responsibilities:
- Provide oversight and management of patient safety contract/vendor activities, including contract review, vendor management support, and safety information reporting.
- Liaise on Pharmacovigilance Agreement (PVA) matters between USO Patient Safety and business operations/other departments.
- Support quality monitoring for supplier/business-partner safety information reporting and PVAs to ensure compliance.
- Oversee safety information reconciliation and QC from suppliers/partners; support Pharmacovigilance System Master File (PSMF) development/maintenance.
- Manage the Patient Safety Contracts Management mailbox; assign/delegate tasks.
- Ensure late reports from suppliers/partners are identified/documented per SOPs; perform root-cause analysis and CAPA as appropriate.
- Support internal/external training; provide guidance to stakeholders on safety reporting requirements (incl. PVAs).
- Contribute to business continuity/resource planning, process/quality improvements, and program/project leadership as needed.
- Provide audit/inspection readiness and support; develop/maintain PV SOPs; maintain FDA/ICH regulatory knowledge.

Qualifications:
- Bachelor’s in medical/life sciences + 8 years relevant experience; or HCP (RN/R.Ph) + 5 years including 3 years in safety reporting. Advanced degree preferred.
- Strong organization/detail; project management; oral/written communication.
- Intermediate Windows, MS Word, PowerPoint, Excel.
- Knowledge of FDA safety reporting and GMP; prior pharma contract/alliance management preferred.
- 0–10% overnight travel.

Benefits:
- Base pay range: $120K–$171K; bonus; long-term incentives/possible company vehicle (per level).
- Medical/dental/vision, life/disability, 401(k), flexible spending, EAP, tuition reimbursement, and voluntary benefits; sick time, flexible vacation, parental leave.

Application instruction:
- For accommodation requests only: call 1-855-411-5290.