Serves as Global Program/Brand Team (GPT/GBT) scientific safety leader for assigned Novartis projects/products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle management (post-approval) and externally.
Responsible for safety issue management from formation of GPT/GBT through Life Cycle Management (post-approval)
Develops and is responsible for key internal Novartis safety documents from the formation of the GPT/GBT through Life Cycle Management. Reviews these documents regularly and updates as required (e.g. when significant new information received). Ensures that these, and all other project-related safety documents, are consistent with one another
Is responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitutes and runs the Safety Management Team. Ensures that this team appropriately reviews all safety data from various sources (e.g. pre-clinical, clinical trial data presented by Clinical Trial Head (CTH) or Medical Scientific Expert (MSE), Pharmacoviligence Expert (PVE), or Pharmacovigilance Leader (PVL), post-marketing, literature) throughout the development process
Provides expert safety input to the clinical development program for assigned projects/brands
Provides expert medical input to trial and project level Drug Safety Monitoring Board activities for assigned projects/products, as required, whilst remaining blinded
Is responsible for initial development and updates of safety information in Basic Prescribing Information (core global labeling), including addressing safety issues optimally in all project/product labeling claims
Is responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Responsible for responses to legal queries and Country Pharma Organization (CPO) requests involving safety issues. Provides integrated safety input into all regulatory documents required during active development. Ensures safety information communicated to EU Qualified Person in a timely fashion
Facilitates involvement of external experts (e.g. authors of white papers, members of trial- specific data safety monitoring boards, ad-hoc support for HA meetings, etc.)
Prepares and presents brand safety issues to internal Novartis Boards and other meetings as required
Provides relevant input for GPT/GBT, Global Clinical Team (GCT) and Clinical Trial Team (CTT) Meetings as needed
Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments
Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities
Attends Health Authority Meetings in person, as required.
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 Degree required.
Specialty Board certification desirable.
Useful additional disciplines: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent)
3 years clinical experience postdoctoral
5 years are in drug development in a major pharmaceutical company (of which 2 years in a global position), including 2 years in safety at an operational or medical position
Experience in preparing or contributing to preparation of clinical safety assessments and regulatory re- ports/submissions involving safety information
Experience in leading cross-functional, multi-cultural teams
Experience with (safety or others) issue management
Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
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