Sr Principal Patient Safety Experience
Sr Principal Patient Safety Experience
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Salary Not Disclosed
1 Vacancy
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 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 Sr. Principal Patient Safety & Experience you serve as the medical and scientific safety leader for assigned Alcon projects or products. You will be trusted to work on the integration analysis and interpretation of safety information from clinical development through postapproval lifecycle. In this role located in Fort Worth Texas a typical day will include:
Provide safety surveillance throughout a products lifecycle through safety trending signal detection and risk management assessments.
Provide safety support to the clinical development team in clinical trials and post marketing programs through identifying monitoring and evaluating safety parameter.
Participates in the resolution of any questions from regulatory agencies and other mitigation activities addressing legal safety and compliance risks.
Perform medical review of single cases and or aggregate data involving assigned products.
Provide medical input into HHAs and responses to reg authorities HCPs local affiliates and Legal on Safety issues.
Provide safety input into clinical and regulatory deliverables including Investigator Brochures study protocols study reports clinical overviews CERs product registrations.
Monitor the clinical safety of assigned products/projects including adverse events and patient impact from tech complaints from studies literature and postmarket surveillance.
Author or provide safety input into the preparation and maintenance of PMSP periodic safety updates product labeling and related documents.
Lead cross functional projects provide guidance on safety topic and collaborate with R&D and business partners.
Provide guidance on event coding causality assessment and determination of anticipated vs unanticipated AE reports.
Identify safety signals based on review of solicited or unsolicited cases. Perform signal triage activities evaluation and presentation to Alcon boards including preparatory activities.
Support BD&L activities HA inspections/audits and project/product recalls.
Collaborate with Franchise Director to develop safety strategy and implementation plan for new product launches.
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 English.
7 Years of Relevant Experience
Preferred Qualifications
OD or MD/DO with Ophthalmology Specialty
HOW YOU CAN THRIVE AT ALCON:
Benefit from working in a highly collaborative environment.
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: 10
Relocation assistance: Yes
Sponsorship available: No
ATTENTION: Current Alcon Employee/Contingent Worker
If 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 Contingent Worker
Alcon is an Equal Opportunity Employer and participates in EVerify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment hiring training promotion or other employment practices for reasons of race color religion gender national origin age sexual orientation gender identity 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
Employment Type
Full-Time
