Submissions Specialist

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 post holder will perform accurate and timely query management (set-up, maintenance, and oversight) and retrospective review activities. The position will also complete other relevant tasks or special assignments under the supervision of a more senior member of staff.

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 impact assessments under supervision.
• Supports investigation, documentation and track compliance related data under supervision.
• Provides input for: Process/system improvement o 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

Training & 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

Working Relationships

Global Medical Safety Operations (GMSO) is a functional area within the Global Medical Organization (GMO) Primary Interface is with Senior Submission Specialist, Submission Scientist and Manager/Director. Additional interface will include but not limited to interactions with GMS Support Desk and Case Processing.

Education & Experience

• 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

Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.