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 ofICSRs 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
- 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 ourclient's site in High Wycombe, Buckinghamshire although there could be flexibility for home working.
Apply: For more information, please contact Lucy Stendall on 01246 457739 or email email@example.com. Please quote reference 50452.