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 integrity, formatting consistency, and adherence to regulatory and internal standards.
• Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases.
• Collaborate closely with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues.
• Maintain up-to-date knowledge of global regulatory requirements and industry best practices for periodic safety reporting.
• Contribute to the development and refinement of QC checklists, templates, and Standard Operating Procedures (SOPs) to standardize and improve review practices.
• Track QC metrics and support continuous improvement initiatives related to the quality and timely delivery of safety reports.

Basic Qualifications and Experience

• Total experience: 5-9 years in relevant roles
• At least 2-3 years of experience specifically in Quality Control (QC)
• Bachelor's or Master's degree in Life Sciences, Pharmacy, or related field