Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to:
entry of safety data onto adverse event database(s) and tracking systems
review adverse events for completeness, accuracy & appropriateness for reporting
write patient narratives
code adverse events accurately using MedDRA
determine expectedness/listedness against appropriate label
perform case medical review & reports to worldwide regulatory agencies
prepare follow-up correspondence consulting the medical staff.
ensure all cases that require
reporting of endpoints to relevant personnel within study timelines
provide independent QC of AE reports for other members of the group
May execute routine quality review of AE reports and aggregate reports
Participate in signal detection, trend and pattern recognition activities
Prepares timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and reports.
Work with Data Management or client on reconciliation of safety databases,
Monitor workflow for assigned studies/programs to all deadlines
Draft/modify and deliver safety presentations
Serious Adverse Event reporting at Investigator meetings
Client capabilities meetings, as appropriate
"Department Overview" to internal clients
Maintains a comprehensive understanding of SOPs, Work Instructions (WI), guidance documents and safety management directive & PV reporting.
Knowledge of other procedural documents, e.g. SOPs, etc. that impact PSS.
Assist in the development of departmental WI and SOPs.
Compliant safety reporting to US and international reporting regulations,
Support/train safety staff in case-handling, adverse event reporting etc