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
• As a DSA, you will be expected to prepare regulatory documentation packets and coordinate the timely completion and submission of required reports to Health Authorities, Ethic Committees, Principal Investigators and business partners.
• Ensure compliance with regulatory reporting requirements for safety reporting in clinical trials.
• Ensure all ICON, Sponsor, and regulatory timeframes are met for the reporting of safety information.
• Ensure the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to sponsors
Candidate Profile
• The successful candidate will have relevant clinical research/pharmaceutical industry experience, preferably in pharmacovigilance/drug safety, with knowledge of medical terminology and coding systems.
• Must be fluent in written and verbal local language with good communication skills and basic computer skills.
• Detail orientated and capable of working effectively within a team environment.
• Medical/science background and/or bachelor’s degree or local equivalent.
Additional Information:
Location: Chennai
Industry Type: Pharma/ Biotech/Clinical Research
Reference: 049588
End Date: 30th August, 2018
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