Company: CK Clinical
Location: High Wycombe
Closing Date: 25 Oct 16
Salary (£): 40,000 - 60,000
Mary Tilston is recruiting for a Submission Specialist to join a highly established research-based pharmaceutical company. This position is a contract role for the duration...
Mary Tilston is recruiting for a Submission Specialist to join a highly established research-based pharmaceutical company. This position is a contract role for the duration of 6 months.
The main purpose of your role will be:
-To be responsible for E2B and manual submissions of individual case safety reports (ICSRs) to regulatory authorities and business partners and provide other functional support to senior submissions specialist, submissions scientist and manager as needed.
-To manage E2B submissions per standardized operating procedural document, review ICSRs for local reportability, make submit / no submit determination and monitor successful transmission.
-To perform other functional duties associated with Local Case Reporting (LCR)/E2B, produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage.
-Monitoring the transmissions / E2B case failure monitoring and (if appropriate) handling.
Further responsibilities will include:
-Liaising with the support desk and / or case processing personnel.
-Preparing the issues for escalation up to manager which may be escalated to QPPV.
-Participating in the User Acceptance Testing (UAT) for upgrade / enhancements to LCR including support of script writing.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-A good first degree in a relevant scientific discipline, or equivalent.
-Experience of safety database systems, local case reporting, queries.
-Experience in related applications (e.g.dsExchange, WebTrader) and knowledge of web-based and Microsoft applications.
This is an excellent opportunity to join one of the leading global pharmaceutical companies with great potential and opportunities to develop your career.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37188 in all correspondence.
9 High Street
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