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.
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.
Salary: 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.
Apply: For more information or to apply for this Submissions Specialist position, please contact Natasha on 01246 457739 or email email@example.com, quoting job ref 51210.
It is essential that applicants hold entitlement to work in the UK.