Job Details

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.