Sr. Associate Pharamocovigilance Operations

Primary Responsibility

• The primary responsibility of this role is to perform quality control (QC) reviews of Amgen's Periodic Aggregate Safety Reports (PASR), including Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER)/Periodic Safety Update Reports (PSUR), Semi-Annual Safety Update Reports (SSUR), Periodic Adverse Drug Experience Reports (PADER/PAER), Device PSURs, and country-specific reports such as Korea PSUR, Brazil PSUR, and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards, supporting the end-to-end writing and documentation process while ensuring timelines are met.

Key Responsibilities

• Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure accuracy of content, data i...