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 6 months.
Up to £26 ph 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
- Hold a degree in a relevant subject or equivalent working experience
- Previous working experience in a regulatory capacity within a pharmaceutical or similar indusrty
- 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
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 50841.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julie Marshall
- Phone: 01438 723 500
- Reference: 50841
Website: CK Group
- Posted: 9th June 2021
- Expires: 7th July 2021