Drug Safety Associate required for top pharmaceutical company based in Buckinghamshire, UK.
Our client, a top pharmaceutical company, are currently looking for a Drug Safety Associate to join their team based in Buckinghamshire. As a Drug Safety Associate, you will be responsible for the receipt and data entry of adverse event reports following Company Standard Operating Procedures, internal business practices and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies. Previous case processing experience is required.
Further key responsibilities of this Drug Safety Associate role will include:
- Triage of incoming cases to determine seriousness for prioritisation of daily workflow.
- Confirmation of Safety Co-ordinator case registry data.
- Database searches as necessary.
- Completion of literature searches as necessary.
- Completion of remaining case data entry, including narrative or auto-narrative.
- Completion of risk and quality (label, approval, manual coding & quality review steps.
- Clarification of unclear or illegible information from the LSO or Call Centre.
- Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician.
- Completion of protocol request forms as necessary.
- Preparation of deviation memo as necessary.
- Request deletions as necessary.
- Single case unblinding.
- Understand relevant safety implications regarding contracts with operating companies and/or marketing partners.
- Review and make suggestions for system and procedure enhancements.
- Participation in inspections and audits, as required .
- Participation in local or global project team.
This Drug Safety Associate position will focus on working on an oncology drug, therefore experience in oncology and the Argus database is a desirable. The ideal candidate for this position will also have a Life Science degree or be a qualified nurse. Pharmacists are not suited unless they have recent experience in Drug Safety.
The successful candidate will enjoy the benefits of working to a global pharmaceutical company, including a competitive rate.
If you would like more information regarding this Drug Safety Associate job, please contact Hendre on Hendre on Tel: +44 (0)1438 870 023 or email firstname.lastname@example.org quoting 19282 to indicate your interest.
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