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
.