Drug Safety Submissions Specialist
*Drug Safety Submissions Specialist -Pharma - 6-month contract*
My client is a Global Biopharmaceutical company and they have a position available for a Drug Safety Submissions Specialist to join their team for an initial 6- month contract.
Within this role the Drug Safety Submissions Specialist will be 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). You will perform accurate and timely query management (set-up, maintenance, and oversight) and retrospective review activities.
* Review ICSRs
* 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
* 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
In order to apply for the Drug Safety Submissions Specialist contract, you should possess a Life science degree and have previous experience of working in the Pharmaceutical Industry within a working knowledge of Safety database systems, local case reporting and queries. You should possess good written and verbal communication skills and a high attention to detail.
You should possess strong IT skill, including knowledge of WebTrader, OST, ArisG , Argus and have the ability to work effectively both independently and as part of a team
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .