Submissions Specialist

2 days left

CK Group
High Wycombe
Up to £26 ph PAYE DOE
22 Jul 2021
29 Jul 2021
Lucy Stendall
Contract Type
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, quoting job ref 51210.

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

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