SEC Recruitment

UK - Safety Data Specialist

Location
England, London, Uxbridge
Salary
Negotiable
Posted
03 Sep 2019
Closes
01 Oct 2019
Ref
119327 - JES
Contact
Jayne Stiff
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Overview of the role :
The Drug Safety Data Specialist role is a regional role and has bases in and outside the UK. The Drug Safety Specialist reports directly to the Drug Safety Manager Safety Data.
The jobholder will :
*Co-ordinate the receipt and initial management of adverse event reports.
*Manage the release of individual case safety reports from the drug safety department in accordance with defined practices.
*Perform event/seriousness data entry and assessment into ARISg.
*Monitor reminder and further follow-up need.
Responsibilities :
*Completeness review of initial AE case reports.
*Determination of non-AEs.
*Identification of product quality reports
*Initiate follow-up if needed & log communication in ARISg CCM
*Determine if AE / Non-AE
*Identify PQ complaint and notify Quality Department.
*Generate daily listing of cases that need subsequent follow-up and send subsequent follow-up letters/queries to ensure due diligence is performed
Requirements :
*B.S. or equivalent in a health related setting Or Commercial diploma
(or the equivalent combination of relevant education or professional experience qualification)
*Minimum 1 years of experience in records management/data
processing/medical transcription setting
*Familiarity with database usage and word processing experience
*Strong communication skills, both written and spoken (English)
*Attention to detail.

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