Job Description Summary

Lead Technology & System Innovation in Japan Patient Safety organization, driving innovation, system operations, data science, and document management to ensure full compliance with global and local pharmacovigilance regulations.
This role is accountable for advancing digital transformation, including the responsible use of AI, to enhance quality, efficiency, and compliance, while enabling data-driven decision making and continuous process improvement.

 

Job Description

Key Responsibilities：

1. Strategy & Leadership

• Define and execute Japan PS technology and innovation strategy aligned with global direction
• Lead and develop a high-performing Technology & System Innovation team
• Drive capability building and resource optimization

2. Digital Innovation & AI

• Lead the responsible and compliant use of AI and digital technologies in Patient Safety
• Identify and prioritize digital innovation opportunities
• Monitor regulatory and technology trends to shape future roadmap

3. System Operations & Compliance

• Ensure Safety IT systems are compliant with global procedures and local regulations
• Oversee implementation and maintenance of pharmacovigilance systems
• Ensure accurate and timely safety reporting

4. Data Science & Analytics

• Drive advanced analytics and insights generation from internal and external data sources
• Enable automation of reporting and data processes
• Enhance data integration and analytical capabilities

5. Process Excellence

• Identify and drive process automation to improve quality, efficiency, and productivity
• Lead system and process improvement projects end-to-end
• Track performance and implement corrective actions when needed

6. Document Management (GxP)

• Oversee lifecycle management of GxP documents
• Ensure compliance and consistency in document processes
• Provide training and governance to stakeholders

7. Stakeholder Management

• Collaborate with cross-functional teams (IT, Regulatory, Clinical, Global PS)
• Engage external vendors, partners, and industry stakeholders
• Maintain alignment with global organization

Key Accountabilities：

• Ensure compliance with pharmacovigilance regulations and internal standards
• Drive delivery of technology and system initiatives
• Manage team performance and resource planning
• Provide expert guidance on safety systems and innovation

Minimum Requirements：

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Data Science, or related field
• Strong experience in pharmacovigilance systems or safety operations
• Proven leadership and team management experience
• Strong communication and stakeholder management skills
• Fluent English and local language proficiency

Preferred Requirements：

• Experience in AI, digital transformation, or data analytics
• Experience managing safety databases (e.g., VeeVa, Argus, etc.)
• Experience in driving automation or system innovation initiatives

People & Impact：

• 6–10 direct reports
• Responsible for budget and resource management
• Critical role ensuring compliance; direct impact on business continuity

Benefits and Rewards

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https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Commitment to Diversity and Inclusion

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Additional Information

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Skills Desired

Clinical Trials, Databasing, Employee Training, Management Reporting, Pharmacovigilance, Safety Science, Team Management, Waterfall Model