Submission Specialist - High Wycombe

Recruiter
CK Group
Location
High Wycombe
Salary
Up to £23 per hour
Posted
13 Jun 2018
Closes
16 Jun 2018
CK Group is recruiting for a Submission Specialist to join a company in the Pharmaceutical industry at their site based in High Wycombe on a 6 month contact initially. The Submission Specialist will be responsible for E2B and manual submissions of individual case safety reports (ICSRs) to Regulatory Authorities and Business Partners; and provides other functional support to Senior Submissions Specialist, Submissions Scientist and Manager as needed. Responsibilities include: Manage E2B submissions per standardized operating procedural document; review ICSRs for local reportability, make submit / no submit determination, monitor successful transmission Perform other functional duties associated with Local Case Reporting (LCRx)/E2B; produce CIOMS / Medwatch and fax/email, distribute, and upload to document storage Perform Outbound Submission Tracking (OST) activities as needed Monitor transmissions / E2B case failure monitoring and (if appropriate) handling Liaise with Support Desk and / or Case Processing personnel Prepare issues for escalation up to manager which may be escalated to QPPV (i.e. clearly articulate the problem) Document and track compliance related data Perform reconciliation Participate in User Acceptance Testing (UAT) for upgrade / enhancements to LCRx including support of script writing Perform archiving activities as necessary Participate in process improvement Maintain knowledge of department policies and procedures Complete development activities as applicable Maintain knowledge on worldwide regulations / guidance related to single case processing activities Skills, knowledge and experience required for the 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, LCRx, ArisG, Argus) Basic understanding of regulatory reporting obligations Attention to detail Sense of urgency Ability to recognize when and what to escalate Global Medical Organization Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained. CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42396 in all correspondence. This job was originally posted as www.totaljobs.com/job/81862033

Similar jobs

Similar jobs