Submissions Manager, GPS Operations The Opportunity:

This position will be responsible for the management, development, and oversight of Global Patient Safety operational activities in the execution of safety information collection and reporting for the clinical programs. Manage and oversee timely and compliant submission of ICSRs, expedited safety reports, and aggregate reports to global health authorities and other required recipients. Ensure PV submissions meet applicable FDA, EMA, ICH, and country-specific regulatory requirements and timelines. Monitor submission compliance, acknowledgments, rejections, and exceptions; investigate issues and drive timely resolution and CAPAs as needed. Maintain submission documentation, metrics, and compliance tracking to support audit and inspection readiness. Partner with Global Patient Safety, Regulatory Affairs, Clinical Operations, Quality, and other cross-functional teams to coordinate safety reporting requirements and deliverables. Oversee PV submission activities performed by CROs, vendors, and partners, including performance monitoring and issue escalation. Develop and maintain PV submission procedures and identify opportunities to improve quality, efficiency, compliance, and scalability.

Required Skills, Experience and Education:

Bachelor's degree in a healthcare field. Minimum of 5 years of relevant experience in pharmacovigilance operational activities. Hands-on experience working with CROs/vendors/partners. Strong background in safety reporting regulatory compliance and global safety reporting/regulations in clinical trials. Able to problem solve, focus on details, multi-task, prioritize options, work independently, anticipate challenges and execute assigned deliverables. Ability to analyze situations and data that requires conceptual thinking and in-depth knowledge of organizational objectives. Ability to persuade others in sensitive/complex situations while maintaining relationships. An innovative team-player with capacity to be effective in a dynamic, continuously improving, and fast-paced company environment. Excellent interpersonal skills including ability to work in cross-functional team environments and with external vendors. Exercise discretion regarding highly confidential internal and external communications.

Preferred Skills:

Master's Degree or higher in a healthcare field. 7+ years of relevant experience in pharmacovigilance operational and submission activities.