Submission Specialist

Submission Specialist

High Wycombe

Until the end of December 2022

Inside IR35

£25-35 per hour

Job Description:

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). 

The successful candidate will perform accurate and timely query management (set-up, maintenance, and oversight) and retrospective review activities. 

Key Responsibilities:

• Review ICSRs within Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures (SOPs), Work Instructions and internal guidance documents.
• Responsible for daily manual or E2B submission of ICSRs to RAs and BPs. Make submit/no submit decisions.
• Record, track and monitor successful transmission in OST/LCRx. Produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage Monitor transmissions / E2B case failure monitoring and (if appropriate) resolution Liaise with Support Desk and / or Case Processing personnel Performs duties as per the rota such as daily /weekly checks and report reviews.
• Monitors SR mailboxes daily, archive and assign emails for action as needed Perform other functional duties associated with Safety Reporting as assigned by a senior member of the team.
• Triaging and prioritization of ICSRs for regulatory reporting by following the business rules and SOPs.
• Perform review submissions review and no submit review. Performs distribution rule creation/update of rules for Safety Reporting, and other departments eg IPV, GCDO SU, USA GRA, OCMS.
• Identifies and resolves issues or prepares for escalation up to more senior member of staff. Perform reconciliation Participate in User Acceptance Testing (UAT) for upgrade / enhancements to safety systems including support of script writing. Prepares agendas, facilitates team meetings and takes minutes. May take lead on key projects under supervision eg bi annual review.
• Supports investigation, documentation and track compliance related data under supervision.
• Provides input for: Process/system improvement, safety reporting initiatives such as regulation changes, compliance, quality metrics preparation for safety reporting AND controlled document creation/update
• Quality Investigations and CAPA activities Provides support for holiday cover according to the Business continuity plan Provides training and mentoring to staff as requested.

Experience and Skills:

• Minimum of 1 years experience in a similar role
• 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, 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