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Drug Safety Associate

052711_2

About the role

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• 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 
• 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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