5 days left
- Full Time
This Submissions Specialist job is with one of the most renowned global pharmaceutical, medical device and consumer health organisations located in High Wycombe, UK. The organisation is a top 10 pharma company and employs over 100,000 professionals worldwide.
The Submissions Specialist will be responsible for E2B and manual submissions of individual case safety reports (ICSRs) to Regulatory Authorities, and will be expected to:
- Provide other functional support to Senior Submissions Specialist
- Recognize when and what to escalate
- Maintain knowledge of department policies and procedures
- Complete development activities as applicable
- Maintain knowledge on worldwide regulations / guidance related to single case processing activities
Skills, Experience and Qualifications:
- 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, LCR, ArisG, Argus)
- Basic understanding of regulatory reporting obligations
- Attention to detail
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Peter Duvall on 0203 0789 542 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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