US-TX, Associate Director, Device Medical Safety 197037BR_1494256564-MZ
|•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.
•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.
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