US-TX, Associate Director, Device Medical Safety 197037BR_1487958963-MZ
|Posting Title - Associate Director, Device Medical Safety|
* 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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