Alcon
Eye Care
Sr.Principal,PatientSafety&Experience
Neural analysis suggests this role is
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“Sr. Principal, Patient Safety & Experience at Alcon. Skills: Safety Surveillance, Signal Detection, Risk Management, Regulatory Standards. Evaluate safety signals. Assess clinical significance of safety data”
What You'll Achieve.
Help maintain patient safety; Ensure all clinical evaluations meet regulatory standards
Industry & Context.
Assess the clinical significance of reported adverse events leading to safety signals/observations and their relevance and potential impact on patient outcomes
Travel Requirements: up to 10%
What They're Looking For.
Must Have
Bachelor’s Degree or Equivalent years of directly related experience, Ability to fluently read, write, understand and communicate in English, 7 Years of Relevant Experience
Nice to Have
M. D Ophthalmologist or O. D.
What You'll Do.
Evaluate safety signals
Assess clinical significance of safety data
Ensure compliance with regulatory standards
Communicate findings to stakeholders
Provide safety surveillance
Perform medically based review of cases
Review adverse event reports
Collaborate with other groups
Provide safety input into clinical trials
Monitor clinical safety of products
Author Post Market Surveillance Plans
Identify safety signals
Perform signal triage activities
Support BD&L activities
Preparation of Health Hazard Assessments
Assess clinical significance of adverse events
Provide clinical input to risk management
Ensure clinical evaluations meet regulatory standards
Provide medically based responses
Communicate clinical findings
Align with Medical Writers
Maintain accurate records
Ensure timely safety documentation
Prepare Medical Safety presentations
How You'll Work.
Team & Collaboration
Collaborate with other associated groups; Align with Medical Writers and regulatory stakeholders; Communicate findings to internal teams and external regulatory bodies; Communicate clinical findings and recommendations to stakeholders, leadership and safety boards
Communication Scope
Communicate findings to internal teams and external regulatory bodies; Communicate clinical findings and recommendations to stakeholders, leadership and safety boards; Provide medically based responses to health authority inquiries
Full Job Description
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Senior Principal, Patient Safety and Experience, you will be responsible for evaluation of safety signals from clinical trials and post-market surveillance data. This position is responsible for assessing the clinical significance of safety data, ensuring compliance with regulatory standards, and communicating findings to internal teams and external regulatory bodies to help maintain patient safety. Provide safety surveillance throughout a product's lifecycle through safety trending, signal detection, and risk management assessments. This role is on-site in the Fort Worth, Texas location and a typical day will include: * Perform medically based review of single adverse event cases and aggregate data involving assigned products. * Review adverse event, clinical trial safety and post-market surveillance reports related to safety signals to identify and evaluate potential safety concerns. * Collaborate with other associated groups to assess the clinical implications of safety signals. * Provide safety input into clinical trials and regulatory deliverables including Investigator Brochures, clinical trial protocols, clinical study reports, clinical overviews, Clinical Evaluation Reports, and product registrations. * Monitor the clinical safety of assigned products/projects, including adverse events, and patient impact from tech complaints from studies, literature and post-market surveillance. * Author or provide safety input into the preparation and maintenance of Post Market Surveillance Plans, periodic saf
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