Description
**Group Purpose**
+ Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
+ Submission of all individual case safety reports to FDA/EMA/BPs
+ Support interactions with business partners (license partners) and vendors for all case intake and processing activities
+ Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures
+ Ensure vendor compliance with approved processes and training requirements
+ Audit & external inspection support
**Job Summary**
**Responsible for:**
+ Support reportable event reconciliation for Amgen sponsored clinical trials
+ 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**
+ Reportable event reconciliation: Perform review of non-matching safety data in clinical and safety databases
+ Oversee/manage vendor clinical safety reconciliation team(s)
+ 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 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
