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Senior Drug Safety Associate

São Paulo
Permanent
Reference: JR062563
This vacancy has now expired.
Description

Job Profile Summary

  • Perform case processing for serious adverse events, serious and non-serious adverse drug reactions, and other medically- related project information, such as adverse events of special interest and clinical endpoints
  • Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing and reporting of safety information
  • Ensure 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 centers on 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 (up to approximately 15%) domestic and/or international as applicable
  • Complete all departmental project activities accurately in accordance with ICON SOPs, Study Specific Procedures, regulatory requirements, and Sponsors processes
  • Review and process serious adverse events, spontaneously reported adverse reactions and/or other medically related information per assigned tasks and study 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
  • Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues
  • Attend project team meetings and teleconferences as required
  • Serve a resource for investigational sites and ICON personnel on safety- related issues
  • Liaise with Sponsor and attend Sponsor meetings, as required
  • Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety Issues
  • Liaise with ICON project manager, and other departments, as appropriate
  • Identify out of scope activities in conjunction with the MSS Functional Lead
  • Train/mentor newly hired DSA staff, as requested
  • Assist with coordination of interdepartmental activities (e.g. listing review, quality control, quality assurance (audits), miscellaneous project activities)
  • Generate study specific procedures for contracted departmental services
  • Assist management with weekly and monthly project status reports
  • Assist with generation of regulatory reports as necessary to ensure regulatory compliance.
  • Conduct safety presentations for start-up meetings, Investigator meetings and other meeting serve as lead DSA on all (including global) medical or safety projects as assigned
  • Actively identify out of scope activities in conjunction with the MSS Functional Lead and/or Clinical Project Manager
  • Assist the MSS Functional Lead (e.g. Medical Monitor) independently
  • Perform other activities as identified and requested by management
 

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