Novartis AG
Basel (City)
10 hours ago
Global Head Mechanistic Safety and Safety Signal Management
- 10 March 2026
- 100%
- Basel (City)
About the job
Summary
Designs and develops safety monitoring strategies for products and approvals. Responsible for pharmacovigilance, including necessary follow-up, risk assessment, and product-relatedness regarding reports of side effects, safety monitoring in clinical trials and post-marketing programs. Participates in clarifying any legal liability and compliance with government regulations. Provides and contributes to trend and safety signal detection and risk management assessment throughout the product lifecycle. Supports clinical development teams in the area of safety.
About the Role
Major Accountabilities
~ Leads an assigned area/therapy area/development unit (TA/DU) of the Medical Safety organization to improve patients' lives & impact Novartis overall results through expertise in safety assessment & medical innovation
~ Ensures optimal patient safety as the highest priority by developing modern safety strategies, managing medical safety processes and capabilities, and accountability for compliance with safety regulations in the assigned TA/DU.
~ Responsible for delivering high-quality, timely & standardized medical safety services within the TA/DU. Provides content guidance and approval of line functions required for all safety documentation.
~ Establishes and maintains common global processes & policies for assessment, analysis, and compliance of medical safety within the assigned area, including documented guidance for coding and, if necessary, assessment of causality/expectation for reports of adverse events.
~ Responsible for building an efficient team within the TA/DU and for recruiting, retaining & developing talent.
~ Prepares safety objectives and evaluates & manages the performance of medical safety staff within the assigned TA/DU.
~ Enhances scientific & clinical experience of physicians/scientists in medical safety.
~ Initiates & maintains productive cross-functional collaboration in medical safety through continuous education and training.
~ Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Key Performance Indicators
~ Achieving unit goals
~ Compliance with Novartis policies and external regulations
~ Compliance, consistency, and quality of safety services
~ Staff development and retention of high-performing employees.
~ Quality of scientific and operational strategy and execution as well as management team input.
Work Experience
~ Strategy development
~ Leadership qualities
~ Representation of the organization
~ Cross-border collaboration
~ Leading large and/or broad multifunctional teams
Skills
~ Leadership
~ Process safety management
~ Compliance
~ Strategy
~ Multicultural team leadership
~ Cross-functional teams
~ Medical strategy
~ Safety scientific insights
~ Leadership
~ Process safety management
~ Compliance
~ Strategy
~ Multicultural team leadership
~ Cross-functional teams
~ Medical strategy
~ Safety scientific insights
Language
English
~ Leads an assigned area/therapy area/development unit (TA/DU) of the Medical Safety organization to improve patients' lives & impact Novartis overall results through expertise in safety assessment & medical innovation
~ Ensures optimal patient safety as the highest priority by developing modern safety strategies, managing medical safety processes and capabilities, and accountability for compliance with safety regulations in the assigned TA/DU.
~ Responsible for delivering high-quality, timely & standardized medical safety services within the TA/DU. Provides content guidance and approval of line functions required for all safety documentation.
~ Establishes and maintains common global processes & policies for assessment, analysis, and compliance of medical safety within the assigned area, including documented guidance for coding and, if necessary, assessment of causality/expectation for reports of adverse events.
~ Responsible for building an efficient team within the TA/DU and for recruiting, retaining & developing talent.
~ Prepares safety objectives and evaluates & manages the performance of medical safety staff within the assigned TA/DU.
~ Enhances scientific & clinical experience of physicians/scientists in medical safety.
~ Initiates & maintains productive cross-functional collaboration in medical safety through continuous education and training.
~ Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
Key Performance Indicators
~ Achieving unit goals
~ Compliance with Novartis policies and external regulations
~ Compliance, consistency, and quality of safety services
~ Staff development and retention of high-performing employees.
~ Quality of scientific and operational strategy and execution as well as management team input.
Work Experience
~ Strategy development
~ Leadership qualities
~ Representation of the organization
~ Cross-border collaboration
~ Leading large and/or broad multifunctional teams
Skills
~ Leadership
~ Process safety management
~ Compliance
~ Strategy
~ Multicultural team leadership
~ Cross-functional teams
~ Medical strategy
~ Safety scientific insights
~ Leadership
~ Process safety management
~ Compliance
~ Strategy
~ Multicultural team leadership
~ Cross-functional teams
~ Medical strategy
~ Safety scientific insights
Language
English
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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