Senior Assoc Pharmacovigilance Operations

**Career Category** ------------------- Safety **Job Description** ------------------- **Job Summary** =============== **Responsible for:** * Support vendor oversight of all case intake and processing activities * Case review * Escalation of case level issues * Support convention-related training delivery * Manage queries on Intake, triage, and data entry of ICSRs * Reporting decision for submitting all expedited safety reports to FDA/EMA * Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts * Reporting of ICSRs within time frames determined by regulations and contracts * Support BP reconciliation as required by safety agreement * Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness * Be representative 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 * Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements * Perform case review * Perform US case follow up activities * Support the development and delivery of convention-related training material * Review and respond to AE intake, triage, and submission queries in a timely fashion * Initiate unblinding as requested * Select cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreements * Ensure compliance of reporting activities with timelines and criteria * Interface with local office staff, vendors, and business partners for case processing as necessary * Escalation of data entry issues identified * Provide LAO E2B support (nullification, redistribution) * Perform BP reconciliation as required by safety agreement * Support the ICSR literature review process * Support reportable event reconciliation for Amgen-sponsored clinical trials. * Support other case processing functions as required. Knowledge and Skills * Understanding of global regulatory requirements for pharmacovigilance * Familiarity with clinical development process * Case processing experience with demonstrated high case level productivity and quality * Attention to detail * Proficiency in safety system  * Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook Education & Experience (Basic) ### Bachelor’s degree and 2 years of directly related experience ### OR ### Associate’s degree and 6 years of directly related experience ### OR ### High school diploma / GED and 8 years of directly related experience  .