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Submissions Specialist

Buckinghamshire   •  Contract/Temporary, Full time

CK Group are recruiting for a Submissions Specialist to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months.
Our client is one of the world\'s leading research-based pharmaceutical companies and is part of a global family of companies.

This Submissions Specialist role will be based at our client?s site in High Wycombe, Buckinghamshire although there could be flexibility for home working.

Up to £26 per hour 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 have equivalent working experience.
  • Previous working experience in a regulatory capacity within a pharmaceutical or similar industry.
  • 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.

For more information or to apply for this Submissions Specialist position, please contact Natasha on 01246 457739 or email pharmacontracts@ckagroup.co.uk, quoting job ref 51210.

It is essential that applicants hold entitlement to work in the UK.

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

  • Agency: CK Group
  • Contact: Lucy Stendall
  • Phone: 01246 457733
  • Reference: 51210
  • Posted: 22nd July 2021
  • Expires: 19th August 2021

CK Group

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