Responsible for daily manual or E2B submission of ICSRs to RAs and BPs.
” Make submit/no submit decisions.
” Record, track and monitor successful transmission in OST/LCRx.
” Produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage
” Monitor transmissions / E2B case failure monitoring and (if appropriate) resolution
” Liaise with Support Desk and / or Case Processing personnel
” Performs duties as per the rota such as daily /weekly checks and report reviews.
” Monitors SR mailboxes daily, archive and assign emails for action as needed
” Perform other functional duties associated with Safety Reporting as assigned by a senior member of the team.
” Triaging and prioritization of ICSRs for regulatory reporting b