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 Director, Global Medical Safety 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:
- Responsible for key internal Alcon safety documents. Develop and update these documents with new or changes in product safety information. Ensure accurate and high quality outputs.
- Responsible for overall signal detection, monitoring, evaluation, and appropriate management of safety information from relevant line functions, clinical studies, post-marketing experience, literature, and other sources. Lead the Safety Management Team (SMT).
- Responsible for post-market surveillance plans, periodic safety updates, product labelling and related documents, including safety information to support product claims.
- Responsible for health hazard assessments and responses to inquiries from health authorities, health care professionals, and legal on safety issues. Prepare safety data for health authority review boards.
- Provide medical and scientific guidance to local affiliates on safety issues.
- Provide medical and scientific input to the clinical development program for assigned projects/brands. This includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required.
- Provide integrated safety input into all regulatory documents required during active product development.
- Ensure timely communication of safety information to Qualified Person for Pharmacovigilance for applicable product portfolio.
- Prepare and present safety issues to Alcon Boards and other meetings.
- Provide guidance on safety topics, initiate, and maintain productive cross-functional collaborations internally with R&D colleagues, business partners, and externally.
- Ensure support for business development and licensing activities, regulatory inspections/audits, and market action activities.
- Foster an innovative culture, ensuring a collaborative, high performing SMT.
- Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables, when needed.
- May function as a deputy for Head, Medical Safety and Compliance for assigned activities.
WHAT YOU'LL BRING TO ALCON:
- Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
- The ability to fluently read, write, understand and communicate in English
- 10 Years of Proven Experience
- 6 Years of Proven Leadership
Preferred Qualifications
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
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Alcon is an Equal Opportunity Employer and participates in E-Verify. 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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.