Job Ref: 213939151

Date: 2021-06-09 15:43:20

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Orion Group Life Sciences have an exciting opportunity for a Submissions Specialist for our Multinational Biopharmaceutical client in the Buckinghamshire Area on an initial 6-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

Education & Experience Requirements:

Describe the minimum knowledge, skill and ability requirements for the position.
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

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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