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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 6 months.

Salary:
Up to £26 ph PAYE depending upon experience, this role is inside IR35

Submissions Specialist Role:

  • Responsible for accurate and timely E2B and manual submission/transmission of individual case safety reports (ICSRs) to Regulatory Authorities (RA) and/or Business Partners (BP)
  • Make submit/no submit decisions.
  • Perform accurate and timely query management (set-up, maintenance, and oversight) and retrospective review activities
  • Record, track and monitor successful transmission

Your Background:

  • Hold a degree in a relevant subject or equivalent working experience
  • Previous working experience in a regulatory capacity within a pharmaceutical or similar indusrty
  • 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

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 50841.


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

  • Agency: CK Group
  • Contact: Julie Marshall
  • Phone: 01438 723 500
  • Reference: 50841
  • Posted: 9th June 2021
  • Expires: 7th July 2021

CK Group

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