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Drug Safety Associate

JR063559

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
* 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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