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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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