Manager, Patient Safety and PV Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in vendor management and oversee the complete safety case processing and reporting activities conducted by the safety vendor and CROs.

• Evaluate safety vendor project plans to confirm that processes and procedures are properly documented and maintained.

• Offer guidance and subject matter expertise to the safety vendor and CROs regarding safety operational activities.

• Track safety vendor deliverables and action items to ensure adherence to timelines.

• Guarantee timely submission of expedited and aggregate safety reports through efficient vendor management and regular assessment of vendor performance metrics.

• Perform routine retrospective quality control on safety cases processed by the safety vendor to maintain a high standard of safety cases and submissions.

• Ensure that the safety vendor’s global safety database (Argus) meets Arcus’s requirements by overseeing database updates (including MedDRA and WHO Drug updates), study configurations, expedited submissions via safety gateways, and management of site queries.

• Aid in the oversight of safety data exchange with partners in compliance with Safety Data Exchange Agreements (SDEAs)/PV agreements.

• Provide safety operational support and expertise to clinical trial study teams as required, including participation in Study Team Meetings and drafting/reviewing Safety Management Plans under the guidance of Safety Operations leadership.

• Collaborate with Data Management to address discrepancies found between safety and clinical databases through SAE reconciliation.

• Partner with Safety Quality and Compliance to ensure readiness for inspections.

• Work alongside Arcus partners to facilitate SDEAs/PVAs.

• Assist in the preparation for internal/external audits and global regulatory inspections.

• Report safety noncompliance issues and trends to Safety Quality and Compliance and aid in investigating quality issues to ensure suitable CAPAs are implemented.

⛳️ Requirements

• Bachelor’s degree in nursing, pharmacy, or other healthcare-related fields.

• Over 4 years of experience in Clinical Safety Operations.

• Extensive knowledge and experience with Argus, document management systems, QC tools, and MedDRA.

• Strong understanding of FDA, EMA, MHRA, and Asia-PAC regulations, ICH guidelines, and safety submissions.

• Proven track record in providing vendor oversight.

• Ability to work effectively within a dynamic, complex, and fast-paced team environment.

• Exceptional interpersonal, communication, analytical, and organizational abilities.

• Demonstrated experience in safety project leadership/management.

• Strong experience in cross-functional collaboration.

🏝️ Benefits

• Health insurance.

• Retirement plans.

• Paid time off.

• Flexible work arrangements.

• Professional development.