•Serves as scientific safety leader for assigned Novartis projects/products.
•Responsible for the integration, analysis, and interpretation of safety information from all sources .
•Responsible for clinical through post-approval safety issue management. Responsible for key internal Novartis safety documents. Develops and updates these documents, as appropriate, with significant new information.
•Ensures accurate and high quality outputs.
•Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information from relevant line functions, clinical studies, post-marketing experience, literature, and other sources.
•Leads the assigned Safety Management Team.
•Responsible for the safety sections in Core Data Sheets and related documents, including safety information to support project/product labeling claims.
•Responsible for safety information in responses to inquiries from health authorities, health care professionals, and legal on safety issues. Prepares safety data for health authority review boards.
•Provides expert medical/scientific guidance to local affiliates on safety issues.
•Provides expert medical/scientific input to the clinical development program for assigned projects/brands.
•Ensures support for licensing activities, regulatory inspections/audits, and project/product recall activities, as needed.
Alcon is an Equal Opportunity Employer and participates in E-Verify. As part of the Novartis Group of Companies, 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, 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 e-mail to firstname.lastname@example.org and let us know the nature of your request and your contact information. 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. Minimum requirements •MD or OD is required.
•Fluent in the English Language.
•At least 5 years of experience in medical device industry (of which 2 years are in a global position), including 2 years in safety at an operational or medical position.
•Clinical expertise in ocular anatomy and ophthalmic procedures. Specialty in glaucoma is preferred.
•Technical expertise in ophthalmic medical devices.
•Experience in medical device development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications. Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
A little about us:
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs.