Drug Safety Associate based in Buckinghamshire, UK
Our client, a leading pharmaceutical company, are currently recruiting for a Drug Safety Associate to join their team based in Buckinghamshire, on a contract basis. You will 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.
Key responsibilities of this Drug Safety Associate role 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 teams.
This position is to work on a oncology drug, therefore experience in oncology and the Argus database is a bonus to hit the ground running (but not essential).
- Candidates must have a Life Science degree or be a qualified nurse.
- Pharmacists are not suited unless they have recent experience in Drug Safety.
- Reasonably local people are preferred.
Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a competitive rate as well as ongoing professional development.
If you would like to hear more about this Drug Safety Associate role, please contact Hendre on Tel: +44 (0)1438 870 023 or email me at firstname.lastname@example.org quoting 19124 to indicate your interest.
Keywords: Drug Safety Officer, Pharmacovigilance Officer, Drug Safety Associate, Pharmacovigilance Associate, Contract, Argus, Life Science, Literature, Case processing.
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