PV Submission Specialist
6 days left
- Experience Level
- Experienced (non-manager)
Hobson Prior are working with a top Global Pharmaceutical company who are looking for a PV Submission Specialist to join them on a 12-month contract in High Wycombe.
Please note that to be considered for this role you must have the right to work in this location.
- Responsible for accurate and timely E2B and manual submission/transmission of individual case safety reports to Regulatory Authorities and/or Business Partners.
- Review ICSRs within Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures, 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 resolution.
- 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 and quality metrics preparation for safety reporting, 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.
- Maintain knowledge of department policies and procedures Complete development activities as applicable Maintain knowledge on worldwide regulations / guidance related to single case processing activities.
- Familiarity with organization and product.
- Organizational skill.
- Problem solving abilities.
- 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.
- Degree and/or relevant work experience.
- Working knowledge of safety database systems, local case reporting, queries.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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