Amgen
Website:
amgen.com
Job details:
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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