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
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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