Associate Director DDIT Development in Patience Safety and Pharmacovigilance Business Analytics
Novartis AG
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Job summary
Novartis AG is seeking an Associate Director, DDIT Development, Patient Safety & Pharmacovigilance Business Analysis, responsible for translating complex PS&PV needs into scalable digital and data solutions. You will guide product owners, engineers, and data scientists to deliver end-to-end analysis, data requirements, and automated reporting with strong regulatory awareness.
The role focuses on modernizing PS&PV capabilities, improving data quality and traceability, and applying AI where
Qualifications
- University degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, Business Administration or a related discipline.
- Significant experience in business analysis, product delivery, process transformation or digital technology within life sciences or another regulated industry.
- Experience defining and managing complex business, system, data and reporting requirements.
- Experience supporting regulated or validated systems, including requirements traceability, testing and User Acceptance Testing.
- Strong knowledge of business process modelling, requirements lifecycle management and Agile or product delivery practices.
- Experience working in global, cross-functional environments with business, technology, data, Quality and vendor stakeholders.
- Demonstrated ability to engage and influence senior stakeholders and drive alignment across organisational boundaries.
- Strong analytical, problem-solving, communication and presentation skills.
Responsibilities
- Lead end-to-end business analysis for PS&PV reporting, data science and analytics initiatives, translating business needs into requirements, user stories, acceptance criteria and solution outcomes.
- Partner with PS&PV stakeholders to translate regulatory, compliance, operational and management reporting needs into scalable reporting and analytics capabilities.
- Define data and reporting requirements across safety data, dashboards, KPIs, regulatory reporting and decision-support solutions.
- Collaborate with Product Owners, Data Architects, Engineers, Data Scientists and Solution Architects to translate business outcomes into scalable technical solutions.
- Identify opportunities to simplify and standardize reporting, reduce manual processes and enable automation and self-service analytics.
- Shape appropriate AI and advanced analytics use cases, with consideration for human oversight, explainability, data quality and compliance.
- Maintain requirements traceability across solution design, testing and validation, supporting GxP and validated-system delivery.
- Influence senior stakeholders and facilitate decisions across global PS&PV, DDIT, Data, Quality, Security and vendor teams.
Skills
Education
Job description
Salary Range: €52,400.00 - €97,400.00 Band Level 5
Location: Barcelona, Spain
The Associate Director, DDIT Development, Patient Safety & Pharmacovigilance Business Analysis is accountable for translating complex Patient Safety and Pharmacovigilance (PS&PV) business needs into scalable, compliant and value-driven digital, data and technology solutions. You will act as a strategic advisor to global PS&PV business leaders, Product Owners and technology teams, providing end-to-end business analysis leadership across business process design, requirements management, data analysis, solution definition, validation, testing, implementation and business adoption. The role will help modernize PS&PV capabilities by simplifying business processes, improving data quality and traceability, enabling automation and applying digital, advanced analytics and artificial intelligence solutions where appropriate.
- Lead end-to-end business analysis for PS&PV reporting, data science and analytics initiatives, translating business needs into requirements, user stories, acceptance criteria and solution outcomes.
- Partner with PS&PV stakeholders to translate regulatory, compliance, operational and management reporting needs into scalable reporting and analytics capabilities.
- Define data and reporting requirements across safety data, dashboards, KPIs, regulatory reporting and decision-support solutions.
- Collaborate with Product Owners, Data Architects, Engineers, Data Scientists and Solution Architects to translate business outcomes into scalable technical solutions.
- Identify opportunities to simplify and standardize reporting, reduce manual processes and enable automation and self-service analytics.
- Shape appropriate AI and advanced analytics use cases, with consideration for human oversight, explainability, data quality and compliance.
- Maintain requirements traceability across solution design, testing and validation, supporting GxP and validated-system delivery.
- Influence senior stakeholders and facilitate decisions across global PS&PV, DDIT, Data, Quality, Security and vendor teams.
- University degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, Business Administration or a related discipline.
- Significant experience in business analysis, product delivery, process transformation or digital technology within life sciences or another regulated industry.
- Experience defining and managing complex business, system, data and reporting requirements.
- Experience supporting regulated or validated systems, including requirements traceability, testing and User Acceptance Testing.
- Strong knowledge of business process modelling, requirements lifecycle management and Agile or product delivery practices.
- Experience working in global, cross-functional environments with business, technology, data, Quality and vendor stakeholders.
- Demonstrated ability to engage and influence senior stakeholders and drive alignment across organisational boundaries.
- Strong analytical, problem-solving, communication and presentation skills.
- Knowledge of Patient Safety and Pharmacovigilance processes and technologies, including safety case management, aggregate reporting, signal management, risk management, PSMF or safety analytics.
- Experience with data, analytics, automation or AI solutions in regulated environments, alongside an understanding of GxP and validation principles.
- Annual base salary: €52,400 - €97,400 EUR gross per year.
- The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
- In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
- We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.
- We also provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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
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
- Analytical Thinking
- Business Acumen
- Business Value Creation
- Communication
- Digital Literacy
- Financial Modeling
- Requirements Analysis
- Requirements Gathering
- Stakeholder Management
- Technology Use
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB)
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally. Read our handbook (PDF 30 MB)
Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.
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