DESCRIPTION:
This is an exciting opportunity to work within the Medical & Safety Services department at ICON, a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a Senior Drug Safety Associate in the validation team, you will be involved in the validation/QC of safety database fields on assigned projects and have the opportunity to progress into project management activities in the long term.
Overview of the Role:
- Your primary responsibility will be validating and quality checking safety database fields on assigned projects.
- You will also provide input for and review relevant safety tracking systems for accuracy/quality and perform safety review of clinical data (case report forms) and patient labs.
- You will also be responsible for documenting and processing serious adverse event cases within ICON, regulatory authorities and sponsor regulations and timeframes.
Role Requirements:
- With a science degree, pharmacy or nursing background or equivalent, you will have previous experience in a drug safety environment together with strong knowledge of medical terminology.
- You will have knowledge of drug safety databases, preferably ARGUS.
- You will have the ability to produce high quality work, with meticulous attention to detail.
- You will be fluent in verbal and written English, with excellent communication skills.
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