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Drug safety associate/ Sr. Drug Safety Associate

Reference: JR066886

"At ICON, it's our People that set us Apart"

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

Job Description:

* 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.

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies

What's Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.


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