Periodic Report Specialist

6 hours ago

Hyderabad, Telangana, India Amgen Inc Full time
  • This position plays a role in the authoring, compilation and peer review of Amgens 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)

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