The purpose of this position is to serve as the scientific safety leader for assigned Alcon projects and/or products. This position is also responsible for the integration, analysis, and interpretation of safety information from all sources (clinical through post-approval lifecycle management and externally).
Responsible for clinical through post-approval safety issue management.
Responsible for key internal Alcon safety documents and for developing and updating 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 Safety Management Team (SMT).
Responsible for the safety sections in Core Data Sheets (CDS) and related documents, including safety information to support project and/or product labeling claims.
Responsible for safety information in responses to inquiries from health authorities, health care professionals, and legal representatives on safety issues.
Prepares safety data for health authority review boards.
Provides expert medical and/or scientific guidance to local affiliates on safety issues.
Provides expert medical and/or scientific input to the clinical development program for assigned projects and/or brands (this includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required, whilst remaining blinded).
Provides integrated safety input into all regulatory documents required during active development.
Ensures timely communication of safety information to Device Qualified Persons.
Prepares and may present brand safety issues to internal Alcon Boards and other meetings.
Provides guidance on and initiates and/or maintains productive cross-functional collaborations internally with colleagues from Group Medical Safety, Business Franchise functions, and externally.
Ensures support for licensing activities, regulatory inspections and/or audits, and project and/or product recall activities.
Fosters an innovative culture, ensuring a collaborative, high performing Safety Management Team.
Serves as and performs activities as Device Vigilance Leader, as needed.
May function as a deputy for Therapeutic Area Safety Leader for assigned activities.