Submissions Specialist

CK Group are recruiting for Submissions Specialist to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 12 months.Salary:Up to £16.00 per hour PAYE depending on experience Submissions Specialist Role: Review ICSRs within Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures (SOPs), Work Instructions and internal guidance documents.Responsible for daily manual or E2B submission ofICSRs to RAs and BPs.Record, track and monitor successful transmission in OST/LCRx.Produce CIOMS / Medwatch and fax/email, distribute, and upload to document storageLiaise with Support Desk and / or Case Processing personnel Your Background: Degree and/or relevant work experienceWorking knowledge of safety database systems, local case reporting, queriesWorking knowledge of related applications (e.g. WebTrader, OST, ArisG, Argus)Basic understanding of regulatory reporting obligationsAttention to detail Company:Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies. Location:This Submissions Specialist role will be based at ourclient's site in High Wycombe, Buckinghamshire although there could be flexibility for home working.

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