Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Submissions Specialist

Eingestellt von Key People

Gesuchte Skills: Support, Client

Projektbeschreibung

Our global client is looking for a Submissions Specialist to join their team on a 12 months contract to start ASAP. You must have strong submissions/E2b reporting experience to be considered for this role. Candidates who are available immediately or on a very short notice period will only be considered due to the nature of the role.

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 standardised 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 equivalent 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 recognise when and what to escalate
Familiarity with organisation and products Organisational skills Problem solving

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Key People