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Submission Specialist

  • Job reference: 924789
  • Location: High Wycombe, Buckinghamshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 09/04/2019

Orion Group are looking for a Submission Specialist on behalf of our Multinational Pharmaceutical client based in the Buckinghamshire area, on an initial 4 month contract.

Responsibilities include:

* 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
* Prepares agendas, facilitates team meetings and takes minutes.
* Provides support for holiday cover according to the Business continuity plan
* Provides training and mentoring to staff as requested. 95%

Desired Experience and Background of successful candidate:

  • 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.