Submissions Specialist

Our global client based in home counties is looking for a Submissions Specialist to join their team on a 12 months contract. This contract is offering an attractive hourly rate and is looking for someone to start as a matter of urgency.

POSITION SUMMARY:

Responsible for E2B and manual submissions of individual case safety reports to Regulatory Authorities and business partners and provides administrative support of Submissions Associate and Manager as needed. The position will also complete other relevant tasks of special assignments as required.

Responsibilities include:

- Manage E2B submissions per standardized operating procedural documents; review ICSRs for local reportability, make submit/no submit determination, monitor successful transmission
- Perform administrative duties associated with LCR/E2B; produce CIOMS/MedWatch and fax/email, distribute, and upload to document storage
- Perform dsExchange activities as needed
- Monitor transmissions/E2B case failure monitoring and (if appropriate) handling
- Liaise with support desk and/or case processing personel
- Prepare issues for escalation up to manager which may be escalated to QPPV (ie. clearly articulate the problem)
- Document and track compliance related data
- Perform reconciliation
- Participate in User Acceptance Testing for upgrade/enhancements to LCR including support of script writing
- Perform documentation storage (archiving)
- Participate in process improvement

Training and Development

- Maintain knowledge of department policies and procedures
- Complete development activities as applicable
- Maintain knowledge on worldwide regulations/guidance related to single case processing activities

Non Technical Skills and Additional Details

Bachelors of Science/Arts Degree or Registered Nurse (Diploma/Associate Degree) or equivelant experience.
Working knowledge of safety database systems, local case reporting, queries
Working knowledge of related applications (dsExchange, WebTrader)
Working knowledge of web-based and Microsoft applications
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