Director, Global Medical Safety, VitRetGlaucoma
Director, Global Medical Safety, VitRetGlaucoma
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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. The Director Global Medical Safety VitRet/Glaucoma will serve as the medical and scientific safety leader for assigned Alcon projects or products. This role will be on-site in our Fort Worth Texas location.
The position is primarily responsible for:
- Responsible for safety management of assigned products in clinical development through post-approval lifecycle.
- 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 governance boards related to assigned platforms. Provide medical safety review and approval of pre and post-market documents (e.g. CER CSR etc.) as Clinical / Medical Expert.
- 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 expert medical and scientific guidance to local affiliates on safety issues.
- Provide expert medical and scientific input to the clinical development program for assigned projects/brands.
- Provide integrated safety input into all regulatory documents required during active product development.
- Prepare and present franchise or brand 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 safety group.
- Provide resource coverage and support project activities across therapeutic areas to ensure timely safety deliverables when needed.
What Youll Bring to Alcon:
- Bachelors Degree or Equivalent years of directly related experience (or high school 18 yrs; Assoc.14 yrs; M.S.7 yrs; PhD6 yrs).
- The ability to fluently read write understand and communicate in English.
- 10 Years of Relevant Experience.
Preferred Qualifications:
- Optometrist or Ophthalmologist (MD or DO)
- Experience in a surgical setting.
- Ophthalmic medical device industry experience in related field (e.g. Medical Safety Clinical R&D etc.).
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 - Yes
- Sponsorship - No
Alcon Careers
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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.
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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY
Alcon 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:
Director
Employment Type
Full-Time
