Drug Safety Associate
About the role
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- Recognize, exemplify and adhere to ICON's values which center 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 (approximately 10%) domestic and/or international
- Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
- Review and process safety events (pre-marketing, post-marketing, device and drug) and/or other medically related information per assigned tasks and project specific procedures
- Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files
- Perform safety review of clinical and diagnostic data as part of case processing
- Assist with generation of project specific procedures
- Act as lead Drug Safety Associate for local or regional projects
- Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER
- Support QPPV as required
- Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues.
- Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate
- Assist with identifying out of scope activities in conjunction with the PV Project lead (as applicable)
- Attend project team and Sponsor meetings (including Investigator meetings) and teleconferences as required
- Perform other activities as identified and requested by management
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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