Career Category Safety Job Description The Pharmacovigilance Operations Manager at Amgen oversees the operations of the pharmacovigilance department, including the handling of adverse event reports, risk management, and safety communication. They ensure compliance with global safety regulations and guidelines.

Job Summary

Responsible for: Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements Provide vendors with resources and training to perform their role Support the analysis and communication of case QC results Lead development and delivery of training materials for case management conventions Support resolution of case related specific queries Management of multiple business partner relationships for case management Support reviews of contract wording for case related data exchange Monitoring compliance regarding regulatory submissions and/or contractual wording for data exchange Assign tasks within Case Management to direct and indirect reports Support management of staff within Case Management Escalation of case processing issues Audit & external inspection support Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Key Activities Day-to-day vendor management issues Interact with other local safety offices Ensure case processing timelines for AE intake, triage and submission are met Assess workload to assist in resource management Support on-boarding and on-going training of vendors Attend management meetings with vendors Support analysis of QC trends Support generating, communicating, and archiving of reports of QC findings Support audits of CAPAs and other actions/recommendations for ICSR quality related measures Perform case review as required Lead development and delivery of convention-related training material Support training of local office staff Perform US case follow up activities Perform BP reconciliation as required by safety agreement Generate and distribute performance metrics (submission compliance, volumes, turnaround times) Support reviews of contract wording for case related data exchange Support regulatory inspection and support for vendor audits/inspections Oversee performance monitoring and relay metrics to vendors Support analysis of QC trends including actions/recommendations Generate, communicate, and archive report of QC findings Knowledge and Skills Understanding of global regulatory requirements for pharmacovigilance Project leadership experience Competence in safety systems

Experience

in supporting inspections or internal audits Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook

Education

&

Experience

(Basic) Master’s degree and 3 years of directly related experience OR Bachelor’s degree and 5 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience, AND Previous experience directly managing teams, projects, programs or directing the allocation of resources . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen