ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post: Drug Safety Associate
Job Description:
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:
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
Candidate Profile:
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 :
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%
Additional Information:
Experience: min. 8 months exp
Location: Chennai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: medical and safety services
Job Code: 10936
End Date: 20th Sep, 2012
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