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
Develops and implements a product safety monitoring strategy and its approval. Responsible for the company drug control program, including necessary monitoring, risk assessment, and product-related adverse effects, overseeing safety in clinical trials and post-marketing programs. Participates in resolving any legal obligations and compliance with government standards. Provides and contributes to the detection of safety trends and signals as well as risk management evaluation for products. Provides safety support to clinical development teams.
About the Role
Major Accountabilities
~ Leads a therapeutic area/development unit (TA/DU) of the medical safety organization to improve patients' lives and impact Novartis' overall outcomes through strong expertise in safety assessment and medical innovation.
~ Ensures optimal patient safety as a priority by developing a cutting-edge safety strategy, driving medical safety processes and capabilities, and ensuring compliance with safety rules within the assigned TA/DU.
~ Responsible for delivering high-quality, timely, and standardized medical safety products across the TA/DU. Provides content guidance and line function approval for all safety documents
~ Establishes and maintains common global processes and guidelines for medical safety assessment, analysis, and compliance in the chosen area, including documented guidelines for coding and causality/expectation assessment of adverse event reports, as required.
~ Responsible for building an effective team within the TA/DU and attracting, retaining, and developing talent
~ Prepares safety objectives and evaluates and manages the performance of medical safety associates within the assigned TA/DU
~ Enhances the scientific and clinical experience of medical safety physicians/scientists
~ Initiates and maintains productive cross-functional collaborations in medical safety through ongoing training and coaching
~ Reports technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt
Key Performance Indicators
~ Achieve group objectives
~ Comply with Novartis guidelines and policy and external regulations
~ Compliance, consistency, and quality of safety deliverables
~ Staff development and retention of high-performing associates.
~ Quality of scientific and operational strategy and its execution, and contribution to management team.
Work Experience
~Strategy development
~People Leadership
~Represent the organization
~Collaborate beyond boundaries
~Lead large and/or diverse multifunctional teams
Skills
~Leadership
~Process safety management
~Regulatory compliance
~Strategy
~Multicultural team leadership
~Cross-functional teams
~Medical strategy
~Safety science
~Leadership
~Process safety management
~Regulatory compliance
~Strategy
~Multicultural team leadership
~Cross-functional teams
~Medical strategy
~Safety science
Language
English
~ Leads a therapeutic area/development unit (TA/DU) of the medical safety organization to improve patients' lives and impact Novartis' overall outcomes through strong expertise in safety assessment and medical innovation.
~ Ensures optimal patient safety as a priority by developing a cutting-edge safety strategy, driving medical safety processes and capabilities, and ensuring compliance with safety rules within the assigned TA/DU.
~ Responsible for delivering high-quality, timely, and standardized medical safety products across the TA/DU. Provides content guidance and line function approval for all safety documents
~ Establishes and maintains common global processes and guidelines for medical safety assessment, analysis, and compliance in the chosen area, including documented guidelines for coding and causality/expectation assessment of adverse event reports, as required.
~ Responsible for building an effective team within the TA/DU and attracting, retaining, and developing talent
~ Prepares safety objectives and evaluates and manages the performance of medical safety associates within the assigned TA/DU
~ Enhances the scientific and clinical experience of medical safety physicians/scientists
~ Initiates and maintains productive cross-functional collaborations in medical safety through ongoing training and coaching
~ Reports technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt
Key Performance Indicators
~ Achieve group objectives
~ Comply with Novartis guidelines and policy and external regulations
~ Compliance, consistency, and quality of safety deliverables
~ Staff development and retention of high-performing associates.
~ Quality of scientific and operational strategy and its execution, and contribution to management team.
Work Experience
~Strategy development
~People Leadership
~Represent the organization
~Collaborate beyond boundaries
~Lead large and/or diverse multifunctional teams
Skills
~Leadership
~Process safety management
~Regulatory compliance
~Strategy
~Multicultural team leadership
~Cross-functional teams
~Medical strategy
~Safety science
~Leadership
~Process safety management
~Regulatory compliance
~Strategy
~Multicultural team leadership
~Cross-functional teams
~Medical strategy
~Safety science
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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