Director, Global Device Medical Safety (Cataract Surgeon)

Novartis Pharmaceuticals Fort Worth , TX 76102

Posted 3 months ago

Job Description:

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.

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Director, Global Device Medical Safety (Cataract Surgeon)

Novartis Pharmaceuticals