Hobson Prior are looking for a Submission Specialist Junior to join one of the world’s largest healthcare companies. This client aims to improve access and affordability to pharmaceuticals enabling healthier communities worldwide. This role will be responsible for accurate and efficient E2B and manual submission/transmission of individual case safety reports to Regulatory Authorities and Business Partners.
- Evaluate ICSRs within Safety Reporting scope of accountability for reportability based on Standard Operating Procedures, Work Instructions and internal guidance documents.
- Accountable for daily manual or E2B submission of ICSRs to RAs and BPs.
- 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.
- Performs duties as per the rota such as daily /weekly checks and report reviews.
- Make submit/no submit decisions.
- You will be responsible for monitoring SR mailboxes daily, archive and assign emails for action as needed.
- Execute other functional duties associated with Safety Reporting as assigned by a senior member of the team.
- Prioritization of ICSRs for regulatory reporting by following the business rules and SOPs.
- Have a meticulous eye to detail.
- Capability to recognize when and what to escalate.
- Familiarity with organization and products.
- Good organizational and problem-solving abilities.
- Degree and/or relevant work experience.
- An understanding of safety database systems, local case reporting, queries.
- Prior experience of related applications (e.g. WebTrader, OST, ArisG, Argus).
- Basic understanding of regulatory reporting obligations.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back 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.