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Drug Safety Associate

India-Chennai
Permanent
Reference: 048166
Description
• Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs • Travel (up to approximately 10%) domestic and/or international as applicable • *Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes • *Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study specific procedures • *Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files • *Attend project team meetings and teleconferences as required • *Serve a resource for investigational sites and ICON personnel on safety-related issues • *Assist with training/mentoring newly hired DSA staff, as requested • *Assist with identifying out of scope activities in conjunction with the MSS Functional Lead • *Assist with generation of study specific procedures • *Liaise with Sponsor and attend Sponsor meetings, as required • *Perform safety review of clinical and diagnostic data • * Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues • *Liaise with ICON project manager, and other departments, as appropriate • *Assist the MSS Functional Lead under supervision • *Act as lead DSA for local or regional projects • Perform other activities as identified and requested by management
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