Safety Data Specialist - CELGJP00007996

  • Location

    Hayes, London

  • Sector:


  • Job type:


  • Salary:

    £20 - £30 per hour

  • Contact:

    Jakub Rurkowski

  • Contact email:

  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


  • Start date:


Safety Data Specialist - £20/£30 p/h - 6 months
Safety Data Specialist - £20/£30 p/h - 6 months
The work location is based in Stockley Park on 6-months contact duration
Pay rate is between £20 - £30 per hour.

* To co-ordinate the receipt and initial management of adverse event reports.
* To execute the distribution and tracking of adverse event follow up materials
* To 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
* Perform Other Manufacturer Notification & any other licensed partner exchanges further to PV agreements

Context and Responsibilities
The Safety Data Specialist role is a regional role based in Switzerland and UK
Reports to Drug Safety Manager Safety Data

Responsible for:
Initial AE case report completeness review
Determination of non-AEs
Initial receipt and data entry of AE and non-AE case reports
Assessment of non-serious case reports
Identification of product quality reports
Distribution and tracking of follow-up materials
Final stages in case report management in accordance with defined procedures
Maintaining submission details within the corporate drug safety database
Maintaining case files to include source documentation and submission records where applicable
Translation of source documents as needed
Data completion
Case Management

Co-ordinate the receipt of case reports, specifically:
* Retrieve case in IRT
* Check initial source doc completeness
* Initiate follow-up if needed & log communication in ARISg CCM
* Perform duplicate search and identify exact duplicate source doc
* Perform initial data entry in ARISg
* Determine if AE / Non-AE
* Identify Non-AE follow-up needs and generate letters and attachments
* Identify PQ complaint and notify Quality Department
* Execute exchange of information (e.g. contractual partners)
* Perform data entry of cases into ARISg as per WP-G-503 and internal timelines per SOP-G-500
* Perform assessment of non-serious cases into ARISg as per WP-G-505 and internal timelines per SOP-G-500

Regulatory Submission
* Maintaining submission details within the corporate drug safety database
* Create CIOMS forms as needed
* Create cover letters to support electronic and manual submissions
* Create submission packages as required

Execute pre-defined follow-up measures and due diligence, specifically:
* Pull list of follow-ups to be sent by day
* Send out follow-up letters
* Update follow-up communication in ARISg CCM
* Generate daily listing of cases that need subsequent follow-up and send subsequent follow-up letters/queries to ensure due diligence is performed
* Initiate reminder of further follow-up as needed
* Elevate outstanding follow-up (clinical trial case)
* Log follow-up measures in ARISg CCM
* Internal Global Safety Dept Development
* Demonstrate knowledge of and compliance with established document management processes, guides, policies, and SOPs.
* Participate in the mentoring and training of new staff
* Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

Preferred Role Qualifications, Experience, Knowledge & Competencies
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education and experience or the equivalent.

* B.S. or equivalent in a health-related setting (or equivalent combination of education and experience)
* 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
* Word processing experience
* Document management and archiving practices
* Strong English written and spoken
* Strong communication skills
* Competencies
* Attention to details
* Time Management
* Prioritization skills
* Team working
* Adaptability
* Organization skills
* Decision Making Authority
* Promote Open Communication
* Initial internal distribution of AE and non AE reports
* Determination of non-AE status
* Determination of Product Complaints
* Identification of AE reports flagged for follow-up
* Determination of outstanding follow up needs
* Initial AE case production, as applicable
* Initial AE case data entry and assessment
* Distributed follow-up requests
* Follow-up request tracking
* Completed safety reports
* Submission records within the corporate drug safety database and case folders