Global Periodic Reports - Senior Coordinator

What you will do

This position plays a role in the design, development, and implementation of operating policies and procedures for maintaining and managing 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
  • Lead all aspects of the publishing approval processes for all PASRs, ensuring timely and compliant submissions.
  • May assist with Integrated Case Management and Coding activities as required

Key Activities:

• Responsible for the generation and assessment of PASR metrics, including all Key Compliance Indicators and Key Performance Indicators
• Responsible for the Quality Assurance activities for PASRs
• Responsible for the publishing approval of all PASRs
• Responsible for the scheduling of all PASR meetings throughout PASR production
• Responsible for the maintenance of PASR training materials, training Assignment Vehicles and Quick Reference Guides
• Acts as the central point of contact for Global Patient Safety for Amgen RIM
• Provides centralized mentoring, training, for Safety and corporate members who work on Periodic Reports.
• Provides support to Integrated Case Management and Coding team as required.

Inspection Readiness:

• Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
• Support audit and inspection deliverables, including but not limited to information requests and response QC.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek should have below qualifications.

Basic Qualifications:

• Doctorate degree OR
• Masters degree and 4 to 6 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR
• Bachelors degree and 6 to 8 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting OR
• Diploma and 10 to 12 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience
• Strategic approach, attention to detail, and the ability to work collaboratively across multiple teams to ensure compliance, operational efficiency, and continuous improvement within Pharmacovigilance Operations.
• Demonstrate knowledge of global aspects of pharmacovigilance
• Strong knowledge of processes and global regulations for pharmacovigilance and periodic / aggregate reporting
• Good knowledge of IT systems and IT standards including document management systems e.g. Veeva vault
• Ability to effectively handle challenging priorities and timelines
• Excellence in oral and written English
• Strong leadership skills, independence, networking and influencing skills

Contribution:

• Ensures Amgen remains in compliance and becomes best in class with regard to periodic / aggregate report processes
• Implements and maintains document standards
• Responsible for successful alignment and tracking of metrics, timelines, and performance indicators for PASR objectives.

Preferred Qualifications:

• BS, RPH, RN HCP, or Life Science with 5-8 years of directly relevant experience (including 6 years of experience in Drug Safety).