Sr. Associate Pharamocovigilance Operations

Job Description:

Responsibilities

•  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).