Support Medical Safety franchises to coordinate, prepare, and track safety documentation for post-production lifecycle management of Alcon medical devices.
Partner with Medical Safety franchises and Safety Data Science to optimize operational efficiencies within the organization.
Collaborates with Safety Data Science to define and gather the relevant safety data outputs from global complaint management system.
Analyzes and presents safety data for Alcon products at Post-Production Risk Reviews on behalf of Global Medical Safety.
Coordinates with cross-functional subject matter experts to author post-market surveillance plans and aggregate safety reports (Device Periodic Safety Updates and Post-Market Surveillance Reports) with minimal supervisory guidance.
Coordinates with R&D Risk Management Team in providing safety updates for Clinical Evaluation Reports, Post-Market Clinical Follow-up, Risk Management Files, and product labelling.
Collaborates with Medical Safety franchises and business partners to monitor the safety profile of newly launched products emerging from aggregate reporting or large data set analyses.
Prepare safety document templates and standard operating procedures in accordance with new or changing regulations.
Collaborates with Medical Safety sub-functions to optimize operational efficiency in post-marketing surveillance activities; facilitates creation or updates of related internal or cross-functional standard operating procedures.
Provides training on emerging medical device regulations and internal processes.
May function as a deputy in Medical Safety franchise activities or special assignments if clinically/medically qualified.
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 email@example.com and let us know the nature of your request and your contact information. Equal Employment Opportunity Posters: If youd like to view a copy of the Alcons affirmative action plan or policy statement, please email firstname.lastname@example.org.
Manager, MDR & Safety Operations
Bachelors Degree or Equivalent years of directly related experience (or high school +13yrs; Assoc.+9yrs; M.S.+2yrs; PhD+0yrs)
The ability to fluently read, write, understand and communicate in English
5 Years of Relevant Experience: preferably in medical device safety, clinical research, or regulatory affairs
Clinical knowledge of ocular anatomy, common ocular conditions / diseases, and ophthalmic treatments or surgical procedures.
Proven ability to analyze, interpret, and discuss safety information relating to multiple therapeutic areas.
Prior experience in scientific / technical writing of device technical files
Solid interpersonal, communication (written and verbal), and presentation skills
Experience with (safety or others) issue management
Ability to work independently and meet targeted timelines in a team-centric environment
Ability to work under pressure, demonstrating initiative and flexibility
Fort Worth, TX
Research & Development
NON-NVS AL RESEARCH & DEVELOPMENT
Alcon Research, LLC.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any 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.