Global Periodic Reports Coordinator

ou'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Global Periodic Reports Coordinator

What you will do

Let's do this. Let's change the world. This position plays a role in the design, development, and implementation of operating policies and procedures for maintaining and handling Amgen's 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:

• Master's degree and 1 to 3 years of relevant experience OR,

• Bachelor's degree and 3 to 5 years of relevant experience OR,

• Diploma and 7 to 9 years of relevant experience

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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