Submissions Specialist

  • Salary: £16.00 PAYE
  • REF Number: 00050452
  • Consultant: Lucy Stendall
  • Contact: 01246 457725
  • Date Published: 21.04.2021
  • Sector: Non-Specific
  • Location: High Wycombe, Home Counties
  • Discipline: Drug Safety And Pharmacovigilance

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 storage
  • Liaise with Support Desk and / or Case Processing personnel

Your Background:

  • Degree and/or relevant work experience
  • Working knowledge of safety database systems, local case reporting, queries
  • Working knowledge of related applications (e.g. WebTrader, OST, ArisG, Argus)
  • Basic understanding of regulatory reporting obligations
  • Attention 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.

Apply: For more information, please contact Lucy Stendall on 01246 457739 or email Please quote reference 50452.

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