Alcon

Eye Care

Sr.Principal,PatientSafety&Experience

$0–0k Fort Worth, Texas, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Eye Care
Problems you'll solve

Assess the clinical significance of reported adverse events leading to safety signals/observations and their relevance and potential impact on patient outcomes

Eligibility Requirements

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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