ICON Clinical Research RMZ Millennia Business Park, Building 3A, 2nd Floor, 143 Dr. M G R Road
Kandhanchavady Chennai 600 096
Drug Safety Associate (All Levels)
Role Responsibility
You 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.
Additional Responsibilities:
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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
Experience and Qualification
With a science degree, pharmacy or nursing background you will have a minimum of 8 months experience in a drug safety environment. You will possess excellent verbal and written communication skills and must be fluent in English. This will be combined with a good knowledge of medical terminology.
In addition you will also require :
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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%
You will have the opportunity to progress your career and may wish to move into Project Management or into other related areas where you can further develop your skill set.
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