Drug Safety Associate
ICON plc
Mexico City
hace 2 días

Summary

  • Perform processing for all types of safety events, and other medically-related project information.
  • Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
  • Assist in ensuring the completion of all departmental project activities accurately in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors
  • 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
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