
Posted 24 days ago
Sr. Principal, Patient Safety & Experience
Alcon
Requirements
Bachelor's Degree or equivalent experience, 7 years of relevant experience, English fluency
Skills
Clinical ResearchPharmacovigilance
About the role
Responsibilities
- Evaluate safety signals from clinical trials and post-market surveillance data to ensure regulatory compliance and patient safety
- Perform medically based reviews of single adverse event cases and aggregate data involving assigned products
- Collaborate with cross-functional groups to assess the clinical implications of safety signals
- Provide safety input for clinical trials and regulatory deliverables, including Investigator Brochures, protocols, and Clinical Evaluation Reports
- Author and maintain Post Market Surveillance Plans, periodic safety updates, and product labeling
- Identify and triage safety signals and present findings to Alcon safety boards
- Support Health Hazard Assessments and provide medically based responses to health authority inquiries
- Ensure all clinical evaluations meet global regulatory standards such as US FDA and EU MDR
Requirements
- Bachelor's Degree or equivalent years of directly related experience
- 7 years of relevant experience in patient safety or a related field
- Fluency in reading, writing, and communicating in English
Preferred Qualifications
- M.D. Ophthalmologist or O.D.
Benefits
- Robust benefits package including health, life, and retirement plans
- Flexible time off
About the Company
Alcon is the global leader in eye care, dedicated to helping people see brilliantly through innovative devices and solutions. Founded in 1945, the company develops and manufactures products for the full life cycle of eye care needs, serving patients in 180 countries worldwide.
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Alcon · Fort Worth
