Description
Responsible for E2B and manual submissions of individual case safety reports to Regulatory Authorities and business partners and provides administrative support of Submissions Associate and Manager as needed. The position will also complete other relevant tasks of special assignments as required.Responsibilities include:
- Manage E2B submissions per standardized operating procedural documents; review ICSRs for local reportability, make submit/no submit determination, monitor successful transmission
- Perform administrative duties associated with LCR/E2B; produce CIOMS/MedWatch and fax/email, distribute, and upload to document storage
- Perform dsExchange activities as needed
- Monitor transmissions/E2B case failure monitoring and (if appropriate) handling
- Liaise with support desk and/or case processing personel
- Prepare issues for escalation up to manager which may be escalated to QPPV (ie. clearly articulate the problem)
- Document and track compliance related data
- Perform reconciliation
- Participate in User Acceptance Testing for upgrade/enhancements to LCR including support of script writing
- Perform documentation storage (archiving)
- Participate in process improvement
Training and Development
- Maintain knowledge of department policies and procedures
- Complete development activities as applicable
- Maintain knowledge on worldwide regulations/guidance related to single case processing activities.
It is important that the candidate has, expedited reporting experience of ICSRs. Someone with ability to work under tight deadlines, attention to detail, good team worker.
To find out more about Real please visit www.realstaffing.com