Pharmacovigilance Workflow Manager

Job Summary

Overseeing end-to-end case processing and safety workflows, the full-time remote Pharmacovigilance Workflow Manager will ensure compliance with regulatory requirements, optimize resource utilization, and monitor case progression while managing workflow performance metrics.

Key responsibilities:

• Manage the movement of safety cases through all processing workflow steps, ensuring timely case progression and coordinating staffing coverage
• Monitor workload distribution and track case processing timelines to comply with regulatory and partner reporting requirements
• Identify workflow bottlenecks, implement corrective actions, and provide performance updates to leadership

Required qualifications:

• BS/BA with 4 to 5 years of safety experience, MS/MA with 4 to 5 years of safety experience, or PharmD with 3 to 5 years of safety experience
• Minimum of 2 years of pharmacovigilance work experience in the US/Canada
• Strong knowledge of safety databases and case management tools
• Good understanding of ICH guidelines and global regulatory requirements for adverse event reporting
• Experience processing AE/SAE reports and working within safety databases