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Drug Safety Associate

JR068042

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

    Benefits of Working in ICON :

    Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

    We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

    ICON is an equal opportunity employer, including disability/veteran, and committed to providing a workplace free of discrimination and harassment.

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