UK - Safety Data Specialist

Highly Competitive
  1. Permanent
  2. Product Specialist
  3. United Kingdom
Uxbridge, London
Posting date: 18 Jun 2019

A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Safety Data Specialist to join their UK-based team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.

Job Responsibilities:

  • Reviewing Initial AE case report completeness.
  • Determining non-AEs Initial receipt and data entry of AE and non-AE case reports.
  • Assessing non-serious case reports and identifying product quality reports.
  • Distributing and tracking of follow-up materials.
  • Maintaining submission details within the corporate drug safety database.
  • Maintaining case files to include source documentation and submission records where applicable.
  • Translating source documents as needed.
  • Retrieving case in IRT.
  • Checking initial source doc completeness.
  • Initiating follow-up if needed & log communication in ARISg CCM.
  • Performing duplicate search and identify exact duplicate source doc.
  • Performing initial data entry in ARISg.
  • Determining if AE / Non-AE.
  • Identifying Non-AE follow-up needs and generating letters and attachments.
  • Identifying PQ complaint and notify Quality Department.
  • Executing exchange of information (e.g. contractual partners).
  • Performing data entry of cases into ARISg as per WP-G-503 and internal timelines per SOP-G-500.
  • Assessing 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.
  • Creating CIOMS forms as needed.
  • Drafting cover letters to support electronic and manual submissions.
  • Creating submission packages as required.
  • Executing 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

Skills and Requirements:

  • 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.
  • Familiarity with document management and archiving practices.
  • Experience with initial internal distribution of AE and non-AE reports.
  • Experience with determining non-AE status.
  • Experience with determining Product Complaints.
  • Experience with identifying AE reports flagged for follow-up.
  • Experience with determining outstanding follow up needs.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Divya Mistry at +44 20 3814 1315 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.