About this role
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
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