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Drug Safety Associate

Kerala
Permanent
Reference: 061415_1573102697
Description

Job Description

* 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

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