Global Periodic Reports Coordinator

What you will do

Lets do this. Lets change the world. This position plays a role in the design, development, and implementation of operating policies and procedures for maintaining and handling Amgens Periodic Aggregate Safety Reports (PASR) processes and associated metrics throughout the product lifecycle.

• Process Development and Oversight
• Contribute to the creation and continuous improvement of operating policies and procedures for PASR team
• Ensure the maintenance of robust systems and processes to support compliance and quality.
• Metrics and Reporting
• Generate, analyze, and assess PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
• Quality Assurance
• Lead quality assurance activities for PASRs to uphold high standards of accuracy and compliance.
• Training and Resource Management
• Maintain and update PASR training materials, and Quick Reference Guides.
• Responsible for overseeing the management and maintenance of assignment vehicles within the Learning Management System (LMS) for PASR team, including external vendors, to ensure compliance with training requirements and operational consistency
• Act as a mentor and centralized resource for training safety and corporate team members involved in Periodic Reporting processes.
• Serve as the central point of contact for Global Patient Safety on matters related to Amgen Regulatory Information Management (RIM).
• Collaborate with and provide support to Global Periodic Report Scientists and other key customers as needed.
• Coordinate and schedule all meetings with cross-functional partners to ensure effective collaboration and alignment
• Oversee the publishing approval processes for all PASRs, ensuring timely and compliant submissions.
• May assist with Integrated Case Management and Coding activities as required

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Masters degree and 1 to 3 years of relevant experience OR,
• Bachelors degree and 3 to 5 years of relevant experience OR,
• Diploma and 7 to 9 years of relevant experience