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Submission Specialist-Junior

  • Job reference: 927834
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 23/09/2019

Orion Group are looking for a Submission Specialist-Junior for our multinational pharmaceutical client based in the Buckinghamshire area on an initial 4-month contract with the potential to extend.

Job Purpose
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.

Main Responsibilities of the role

  • 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 e.g. 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 e.g. bi annual review
  • Supports impact assessments under supervision
  • 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
  • Training and 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
  • Reports directly to Manager or Director, Safety Reporting, GMSO 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

Desired Experience and Background of the successful candidate

  • 2 - 4 years' experience
  • Basic Excel and Word essential. Basic PowerPoint & intermediate Excel desirable
  • 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

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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