Career Category

Safety

Job Description

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