What are the responsibilities and job description for the Sr Principle, Patient Safety & Experience position at U341 Alcon Research, LLC. Company?
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 Sr. Principle, 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 post-approval lifecycle. In this role, located in Fort Worth, Texas , a typical day will include :
Provide safety surveillance throughout a product's 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 post-market 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 YOU'LL BRING TO ALCON :
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
Preferred Qualifications
OD, or MD / DO with Ophthalmology Specialty
HOW YOU CAN THRIVE AT ALCON :
Benefit from working in a highly collaborative environment.
Join Alcon’s 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
