Drug Safety Associate- South East
Our client is a dynamic CRO that supports various companies at all stages of the product lifecycle, from Phase I clinical trials to product launch and beyond. They provide services in numerous areas including clinical research, drug safety and regulatory affairs and are currently seeking an experienced Drug Safety Associate to join their expanding team.
Duties:
Processing and data entry of SAE reports.
Writing medical narratives with medical input from a physician.
Development and maintenance of SAE files and tracking systems.
Collation and analysis of drug safety data for submission to Sponsors.
Participation in the set-up of Sponsors' Pharmacovigilance systems including Sponsor registration with the Eudravigilance reporting system.
Participation in the process of developing and review of SOPs.
Preparation and review of periodic safety reports.
Requirements:
1-2 years experience in Pharmacovigilance/Drug Safety.
BSc in a life Sciences or equivalent.
Good Knowledge of MedDRA and MedDRA browser.
Good attention to detail.
Keywords: Drug Safety Pharmacovigilance Officer Associate Executive PSUR SAE MedDRA CRO
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