Patient Safety Operations Manager

Job Summary

Supporting the development and oversight of safety case processing and reporting, the full-time Contractor Manager of Patient Safety and Pharmacovigilance Operations will manage vendor oversight, ensure compliance with safety reporting timelines, and collaborate with cross-functional teams in a remote capacity.

Key responsibilities

• Manage vendor oversight for safety case processing and ensure compliance with safety reporting activities
• Provide operational support to clinical trial teams and assist in safety management plan development
• Conduct quality control of safety cases and ensure timely submission of safety reports

Required qualifications

• Bachelor's degree in nursing, pharmacy, or related healthcare field
• 4+ years of experience in Clinical Safety Operations
• Strong knowledge of Argus and safety submission regulations (FDA, EMA, etc.)
• Proven experience in vendor oversight and project management
• Oncology experience is strongly preferred