ICON Plc (Chennai) requires Drug Safety Associates
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialise in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies
Post:Drug Safety Associate
The desired candidate will be responsible for monitoring and tracking Serious Adverse Events, serious and non serious drug adverse reactions and other medically related project information. You will ensure that all ICON, Sponsor and Regulatory timelines are met for the processing ad recording of safety information.
* Document and process serious adverse event reports within ICON, regulatory authorities and sponsor regulations and timeframes
* Provide input for and review relevant safety tracking systems fro accuracy and quality
* Perform safety review of clinical data (case report forms) and patient labs
* Assist medical monitor in documentation and processing routine exception and re-screen approvals
* Liaise with investigational sites and reporters on safety related issues
* Serve as medical resource to investigational sites and ICON personnel on safety related issues
* Perform safety related training for extra-department ICON staff.
# Degree in life science/pharmacy or nursing background with atleast 8 months of experience in drug safety environment.
# Fluent in english
# good knowledge of medical terminology.
# Good basic computer skills in MS office applications and data base use
# Produce high quality work and be detail orientated
# Be able to prioritise your work to meet required deadline
# Be willing to travel up to 10%
Experience: 8 months
Education: B.Pharm, M.Sc
Industry Type: Clinical research
Functional Area: Health care
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