Sr 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  .