Sr Principal, Patient Safety & Experience at Alcon Research

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 youll 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 products 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 issuesAssess 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.What Youll Bring to Alcon:Bachelors Degree or Equivalent years of directly related experience (or high school15 yrs; Assoc.11 yrs; M.S.4 yrs; PhD3 yrs)The ability to fluently read write understand and communicate in English7 Years of Relevant ExperiencePreferred Qualifications:M.D Ophthalmologist or O.D.How You Can Thrive at Alcon:Join Alcons mission to provide outstanding innovative products and solutions to improve sight improve lives and grow your career!Alcon provides robust benefits package including health life retirement flexible time off and much more!Travel Requirements: up to 10%Relocation - YesSponsorship - NoAlcon CareersSee your impact at ATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon please click the appropriate link below to apply on the Internal Career site.Find Jobs for EmployeesFind Jobs for Contingent WorkerALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFYAlcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please send an email to and let us know the nature of your request and your contact information.Required Experience:Senior IC Key Skills Business Development,Classroom Experience,Dayforce,Go,Cloud Computing,AWS,Teaching,Administrative Experience,Leadership Experience,negotiation,SAS,Data Analysis Skills Employment Type : Full-Time Experience: years Vacancy: 1