Sr. Principal, Patient Safety & Experience

Alcon•Fort Worth, TX

22h•Onsite

About The Position

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 safety updates, product labeling and related documents. Identify safety signals based on review of solicited or unsolicited cases. Perform signal triage activities, evaluation, and presentation to Alcon safety boards, including preparatory activities. Support BD&L activities, HA inspections/audits and project/product recalls, as assigned. Preparation and maintenance of Health Hazard Assessments and responses to regulatory authorities, HCPs, local affiliates and Legal on Safety-related issues Assess the clinical significance of reported adverse events leading to safety signals/observations and their relevance and potential impact on patient outcomes. Provide clinical input to help guide risk management safety decisions. Regulatory Compliance: Ensure all clinical evaluations meet regulatory standards (e.g., US FDA, EU MDR, etc) and prepare clinical sections of regulatory submissions. Provide medically based responses to health authority inquiries on safety data and information. Communicate clinical findings and recommendations to stakeholders, leadership and safety boards. Align with Medical Writers and regulatory stakeholders on safety documentation and communication. Maintain detailed and accurate records of clinical evaluations and regulatory communications. Ensure timely and thorough safety documentation that meets internal and external standards. Prepare Medical Safety presentations for Escalations and support analysis during Escalation meetings from the Medical Safety perspective, as assigned.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience

Nice To Haves

M.D Ophthalmologist or O.D.

Responsibilities

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 safety updates, product labeling and related documents.
Identify safety signals based on review of solicited or unsolicited cases.
Perform signal triage activities, evaluation, and presentation to Alcon safety boards, including preparatory activities.
Support BD&L activities, HA inspections/audits and project/product recalls, as assigned.
Preparation and maintenance of Health Hazard Assessments and responses to regulatory authorities, HCPs, local affiliates and Legal on Safety-related issues
Assess the clinical significance of reported adverse events leading to safety signals/observations and their relevance and potential impact on patient outcomes.
Provide clinical input to help guide risk management safety decisions.
Ensure all clinical evaluations meet regulatory standards (e.g., US FDA, EU MDR, etc) and prepare clinical sections of regulatory submissions.
Provide medically based responses to health authority inquiries on safety data and information.
Communicate clinical findings and recommendations to stakeholders, leadership and safety boards.
Align with Medical Writers and regulatory stakeholders on safety documentation and communication.
Maintain detailed and accurate records of clinical evaluations and regulatory communications.
Ensure timely and thorough safety documentation that meets internal and external standards.
Prepare Medical Safety presentations for Escalations and support analysis during Escalation meetings from the Medical Safety perspective, as assigned.