US-TX, Brand Safety Leader, Medical Devices 232351BR-MZ
Brand Safety Leader, Medical Devices
Global Drug Development
CMO & PATIENT SAFETY GDD
Fort Worth, TX
Research & Development
Serve as scientific safety leader for assigned Novartis projects/products. Responsible for the integration, analysis, and interpretation of safety information from all sources (clinical through post-approval lifecycle management and externally).
1.Responsible for clinical through post-approval safety issue management. 2.Responsible for key internal Novartis safety documents. Develop and update these documents, as appropriate, with significant new information. Ensure accurate and high quality outputs.
3.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. Lead the Safety Management Team (SMT).
4.Responsible for the safety sections in Core Data Sheets (CDS) and related documents, including safety information to support project/product labeling claims.
5.Responsible for safety information in responses to inquiries from health authorities, health care professionals, and legal on safety issues. Prepare safety data for health authority review boards.
6.Provide expert medical/scientific guidance to local affiliates on safety issues.
7.Provide expert medical/scientific input to the clinical development program for assigned projects/brands. This includes input to Data Safety Monitoring Board and Safety Adjudication Committee activities, as required, whilst remaining blinded.
8.Provide integrated safety input into all regulatory documents required during active development.
9.Ensure timely communication of safety information to Device Qualified Person.
10.Prepare and may present brand safety issues to internal Novartis Boards and other meetings.
11.Provide guidance on and initiate/maintain productive cross-functional collaborations internally with colleagues from Group Patient Safety, Business Franchise functions, and externally.
12.Ensure support for licensing activities, regulatory inspections/audits, and project/product recall activities, as needed.
13.Foster an innovative culture, ensuring a collaborative, high performing Safety Management Team.
14.Serve as and performs activities as Device Vigilance Leader, as needed. 15.May function as a deputy for Therapeutic Area Safety Leader for assigned activities.
Timeliness and quality of safety analyses, interpretations, and presentations. Compliance with internal and external regulations and procedures.
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.
MD or OD is required. Useful additional degrees: Post-graduate science degree, Master of Public Health in Epidemiology, or equivalent.
Master of Science or health-related discipline is considered English
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.
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. Experience with medical writing and delivering high quality documents.
Knowledge of global regulatory requirements for safety reporting and labeling.
Experience in leading cross-functional, multi-cultural teams.
Experience with (safety or others) issue management. Excellent written and verbal communications skills.
Ability to work under pressure and demonstrate initiative.
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