Career CategorySafetyJob DescriptionJob SummaryResponsible for:Support vendor oversight of all case intake and processing activitiesCase reviewEscalation of case level issuesSupport convention-related training deliveryManage queries on Intake, triage, and data entry of ICSRsReporting decision for submitting all expedited safety reports to FDA/EMAEnsuring that individual ICSRs are evaluated for reporting in compliance with regulations and contractsReporting of ICSRs within time frames determined by regulations and contractsSupport BP reconciliation as required by safety agreementUndertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readinessBe representative 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 ActivitiesSupport ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirementsPerform case reviewPerform US case follow up activitiesSupport the development and delivery of convention-related training materialReview and respond to AE intake, triage, and submission queries in a timely fashionInitiate unblinding as requestedSelect cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreementsEnsure compliance of reporting activities with timelines and criteriaInterface with local office staff, vendors, and business partners for case processing as necessaryEscalation of data entry issues identifiedProvide LAO E2B support (nullification, redistribution)Perform BP reconciliation as required by safety agreementSupport the ICSR literature review processSupport reportable event reconciliation for Amgen-sponsored clinical trials.Support other case processing functions as required.Knowledge and SkillsUnderstanding of global regulatory requirements for pharmacovigilanceFamiliarity with clinical development processCase processing experience with demonstrated high case level productivity and qualityAttention to detailProficiency in safety system Microsoft Suite: Word, Excel, PowerPoint, Project, OutlookEducation & Experience (Basic)Bachelor’s degree and 2 years of directly related experienceORAssociate’s degree and 6 years of directly related experienceORHigh school diploma / GED and 8 years of directly related experience .