Periodic Report Specialist

This position plays a role in the authoring, compilation and peer review of Amgen’s Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met.

Key Responsibilities:

Compilation and authoring of PASRs

• Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment
• Drive report timelines and escalate risks or delays to team leads or management
• Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template.
• Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists
• Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows.
• Maintain and archive accurate records and documentation throughout the report process.
• Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World).
• Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs)
• Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes
• Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists
• Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
• Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
  
  

• May assist with Literature Management activities as required