Drug Safety Officer

Surrey  ‐ Onsite
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Description

The Drug Safety Associate will be responsible for:
  • Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
  • Review, rank, verify, process and document: event terms; case classifications (validity, seriousness) special scenarios; product complaint information; reportability with due date; and accuracy and consistency. Based on assessment of cases, process accordingly.
  • Review case criteria to determine the appropriate workflow for case processing.
  • Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
  • Write and edit the case narrative.
  • Determine and perform appropriate case follow-up, generating follow-up letters
  • Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
  • Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
  • Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
  • Consistently apply regulatory requirements and Company policies


Minimum requirements:
  • A BSc is essential.
  • Experience and skill with medical writing an advantage
  • Ability, with supervision, to solve routine problems and to surface issues constructively
  • Ability to make basic decisions with an understanding of the consequences
  • Experience in Pharmacovigilance, and with the Argus Safety database, is essential
  • Demonstrated computer literacy, particularly in the use and management of relational databases
  • Ability to work under supervision in a matrix organization


If you have previous experience in Drug Safety within a Pharmaceutical company or Clinical research organisation please email me with your interest and availability.
Start date
08/2015
Duration
6 Months
From
Real Staffing
Published at
11.08.2015
Project ID:
963785
Contract type
Freelance
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