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 is responsible for E2B and manual submissions of individual case safety reports (ICSRs) to Regulatory Authorities and Business Partners; and provides other functional support to Senior Submissions Specialist, Submissions Scientist and Manager as needed. The position will also complete other relevant tasks of special assignments as required.
- Manage E2B submissions per standardized operating procedural document; review ICSRs for local reportability, make submit / no submit determination, monitor successful transmission
- Perform other functional duties associated with Local Case Reporting (LCRx)/E2B; produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage
- Perform Outbound Submission Tracking (OST) activities as needed
- Monitor transmissions/E2B case failure monitoring and (if appropriate) handling
- Liaise with Support Desk and/or Case Processing personnel
- Prepare issues for escalation up to manager which may be escalated to QPPV (i.e. clearly articulate the problem)
- Document and track compliance related data
- Perform reconciliation
- Participate in User Acceptance Testing (UAT) for upgrade / enhancements to LCRx including support of script writing
- Perform archiving activities as necessary
- Participate in process improvement
- Maintain knowledge of department policies and procedures
- Complete development activities as applicable
- Maintain knowledge on worldwide regulations / guidance related to single case processing activities 95%
Education, Skills and Experience:
- 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, LCRx, ArisG, Argus)
- Basic understanding of regulatory reporting obligations
- Attention to detail
- Sense of urgency
- Ability to recognize when and what to escalate
- Familiarity with organization and products
- Organizational skills
- Problem solving abilities
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 Numhom Sudsok on +44 203 8718 093 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.