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Submissions Specialist

Buckinghamshire   •  Contract/Temporary, Full time


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 of ICSRs 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 our client\'s site in High Wycombe, Buckinghamshire although there could be flexibility for home working.

Apply:
Please quote reference 50452.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 50452
  • Posted: 21st April 2021
  • Expires: 19th May 2021

CK Group

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