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.
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 of ICSRs 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
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.
Please quote reference 50452.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Lucy Stendall
- Phone: 01246 457733
- Reference: 50452
Website: CK Group
- Posted: 21st April 2021
- Expires: 19th May 2021