SAFETY DATA SPECIALIST

Recruiter
Undisclosed Company
Location
Uxbridge, London
Salary
£25 - £30 per hour
Posted
08 Aug 2019
Closes
05 Sep 2019
Ref
CELGJP00008213
Contact
Abbas Anwar
Sector
IT
Job Type
Temporary
Hours
Full-time

SAFETY DATA SPECIALIST - STOCKLEY PARK, UXBRIDGE - £25/£30 per hour - 6 Months

The work location is in STOCKLEY PARK, UXBRIDGE and is a 6 months contract.

Pay rate is between £25 - £30 per hour.

The role is working for a well-established, biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders

Purpose:

  • 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

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 Submissions

  • 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:

Qualifications:

  • S. or equivalent in a health-related setting (or equivalent combination of education and experience) or Commercial diploma or the equivalent combination of relevant Education or professional experience qualification

Experience:

  • Minimum 1 years of experience in records management/data processing/medical transcription setting

Knowledge:

  • 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

If you are relevant or interested don't delay, contact me on 0161 924 1416

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