Pharmacovigilance Operations Manager

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 requirementsProvide vendors with resources and training to perform their roleSupport the analysis and communication of case QC resultsLead development and delivery of training materials for case management conventionsSupport resolution of case related specific queries Management of multiple business partner relationships for case management Support reviews of contract wording for case related data exchangeMonitoring compliance regarding regulatory submissions and/or contractual wording for data exchangeAssign tasks within Case Management to direct and indirect reportsSupport management of staff within Case ManagementEscalation of case processing issuesAudit & external inspection supportUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibilityPerforms 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 issuesInteract with other local safety officesEnsure case processing timelines for AE intake, triage and submission are metAssess workload to assist in resource managementSupport on-boarding and on-going training of vendorsAttend management meetings with vendorsSupport analysis of QC trendsSupport generating, communicating, and archiving of reports of QC findingsSupport audits of CAPAs and other actions/recommendations for ICSR quality related measuresPerform case review as requiredLead development and delivery of convention-related training materialSupport training of local office staff Perform US case follow up activitiesPerform BP reconciliation as required by safety agreementGenerate and distribute performance metrics (submission compliance, volumes, turnaround times)Support reviews of contract wording for case related data exchangeSupport regulatory inspection and support for vendor audits/inspectionsOversee performance monitoring and relay metrics to vendorsSupport analysis of QC trends including actions/recommendationsGenerate, communicate, and archive report of QC findings Knowledge and Skills Understanding of global regulatory requirements for pharmacovigilanceProject leadership experienceCompetence in safety systemsExperience in supporting inspections or internal auditsMicrosoft Suite: Word, Excel, PowerPoint, Project, Outlook Education & Experience (Basic) Masters degree and 3 years of directly related experience OR Bachelors degree and 5 years of directly related experience OR Associates 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 .