Sr. Principal, Patient Safety & Experience

Alcon

Fort Worth, Texas, United States
Not specified; not specified; robust benefits pyck...
Review adverse event cases and aggregate data
Assess clinical significance of safety signals
Ensure compliance with us fda and eu mdr standards
This role is responsible for evaluating safety signals from clinical trials and post-market surveillance data to ensure patient safety

Job Summary

  • This role is responsible for evaluating safety signals from clinical trials and post-market surveillance data to ensure patient safety.
  • The position requires assessing the clinical significance of reported adverse events and preparing regulatory submissions for bodies like the US FDA.
  • Alcon offers a robust benefits package including health, life, retirement, and flexible time off for this on-site position in Fort Worth, Texas.

Matching Summary

This role is responsible for evaluating safety signals from clinical trials and post-market surveillance data to ensure patient safety.

Salary

Not specified; Not specified; Robust benefits package including health, life, retirement, and flexible time off

Skills & Requirements

Must-have

  • Review adverse event cases and aggregate data
  • Assess clinical significance of safety signals
  • Ensure compliance with US FDA and EU MDR standards
  • Prepare Post Market Surveillance Plans and periodic updates
  • Collaborate with internal teams on risk management

Nice-to-have

  • Fluent English communication skills
  • Experience with Health Hazard Assessments
  • Support for BD&L activities and audits
  • Ability to present to safety boards

Key Requirements

  • Bachelor's degree or equivalent years of experience
  • 7 years of relevant experience preferred
  • M.D. Ophthalmologist or O.D. qualification preferred
  • Must be able to work on-site in Fort Worth, Texas

Work Rights

Not specified

Tailored Resume

Cover Letter