submissions specialist in high wycombe

09 April 2019
ruby willard, randstad cpe
job type
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high wycombe, south east
sub specialism
job type
working hours
reference number
ruby willard, randstad cpe
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job description

Are you looking for a new role as a Submissions Specialist? Do you want to be responsible for E2B and manual submissions of individual case safety reports (ICSRs) to Regulatory Authorities and Business Partners? If the answer is yes, this role is for you!

This is a new contract opportunity to play a key role and work for a leading Pharmaceutical company, based in High Wycombe with free on site parking.


* 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
* 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
* Maintain knowledge of department policies and procedures
* Complete development activities as applicable
* Maintain knowledge on worldwide regulations / guidance related to single case processing activities

Education and qualifications:

* 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

If this Submissions Specialist role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.