Novartis safety lead who is responsible for oversight of the medical safety function across all Novartis franchises and divisions including Pharma GenMed, Pharma Oncology, Alcon devices and Sandoz. Responsible for the medical safety function, which includes the oversight of safety signal evaluation for Novartis and class-related products from DDP to marketing authorization divestment.
Responsibility also includes cross functional interactions with Pre-Clinical Safety, Clinical Development, Medical Affairs, Epidemiology, Legal and Production in their relation to medical safety in humans. The medical head co-ordinates activities with other Patient Safety line units in order to ensure consistent handling of Serious Adverse Events, post-marketing Adverse Events and device incidents in single and aggregate reports.
MANAGEMENT RESPONSIBILITIES INCLUDE
Strategic leadership and overall management of Novartis medical function members globally. Directly manage all Therapeutic Area Safety Leaders, Multi Program Heads and Divisional Medical Safety Heads globally.
Performance appraisals including objective setting, mid-year and annual performance evaluation, career development and other management issues for medical function team members
Establishing and maintaining common global and uniform standards, poli-cies, procedures and guidelines for the correct handling of medical safety data across Novartis medical safety groups
Contributing to overall training of Medical Safety physicians, including medical, scientific and safety training and sharing of best practices
Initiating and maintaining productive cross-functional medical safety collaborations with colleagues from Clinical Research and Medical Affairs, Drug Regulatory Affairs, Medical Information Processing and Statistics, Pharmaco-epidemiology, Global Clinical Safety Operations, other related departments and with expert panels and other external scientific contacts
Managing the travels & accommodations and the training budgets of medical function within the given limits including a) budget of headquarters sites b) assuring that there is application of uniform standards, policies and procedures as related to financial procedures.
Performing activities related to Franchise Safety Lead and equivalents in other divisions (see Franchise Safety Lead role profile)
Key Performance Indicators
No critical findings in regulatory inspections of Medical Function deliverables (quality of medical evaluations in PSUR, RMP and medical reviews)
At least 98% of internal metrics (KPIs) for the medical function
Effectiveness of safety intelligence activities to influence safety regulatory policy and drive Novartis safety strategy
Recruitment, retention and development of talent in medical function
Efficiency of medical function processes/resource usage/adequacy of re-source estimation
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.
Medical Degree, preferably with board-certified specialty
English and reliable understanding in another major language (e.g. French, German, Spanish) desirable.
Required experience (12-15 years):
At least 2 years specialty training in a teaching hospital
10 years in drug development in a major pharmaceutical company (of which 3 are in a global position and 5 are in safety at an operational or medical position)
Proven track record
- in managing safety or other critical development issues
- in leading cross-functional, multi-cultural teams
- in managing 2- 8 direct reports
Knowledge of global regulations for report of medical safety
Ability to use MS office tools, e-mailing and other databases productively
Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications
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