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Novartis

Global pharmaceutical company delivering science-based innovations

Associate Director DDIT Development in Patient Safety and Pharmacovigilance Business Analytics

Business AnalysisPosted on Nov 10
Full-timeBarcelona, Spain

About the Job

Requirements

  • A university degree in Computer Science, Information Technology, Engineering, Life Sciences, Pharmacy, Business Administration, or a related discipline is required.
  • Significant experience in business analysis, product delivery, process transformation, or digital technology within life sciences or another regulated industry is required.
  • Experience defining and managing complex business, system, data, and reporting requirements is required.
  • Experience supporting regulated or validated systems, including requirements traceability, testing, and User Acceptance Testing, is required.
  • Strong knowledge of business process modelling, requirements lifecycle management, and Agile or product delivery practices is required.
  • Experience working in global, cross-functional environments with business, technology, data, Quality, and vendor stakeholders is required.
  • The ability to engage and influence senior stakeholders and drive alignment across organisational boundaries is required.
  • Strong analytical, problem-solving, communication, and presentation skills are required.

Responsibilities

  • Lead end-to-end business analysis for Patient Safety and Pharmacovigilance reporting, data science, and analytics initiatives, translating business needs into requirements, user stories, acceptance criteria, and solution outcomes.
  • Partner with Patient Safety and Pharmacovigilance 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, key performance indicators, 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 standardise reporting, reduce manual processes, and enable automation and self-service analytics.
  • Shape appropriate artificial intelligence and advanced analytics use cases, considering 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 Patient Safety and Pharmacovigilance, DDIT, Data, Quality, Security, and vendor teams.

Desired Qualifications

  • Knowledge of Patient Safety and Pharmacovigilance processes and technologies, including safety case management, aggregate reporting, signal management, risk management, Pharmacovigilance System Master File, or safety analytics.
  • Experience with data, analytics, automation, or artificial intelligence solutions in regulated environments, alongside an understanding of GxP and validation principles.

About the Company

Novartis

Global pharmaceutical company delivering science-based innovations

Novartis is a global pharmaceutical company that uses science-based innovations to develop treatments and improve patient outcomes worldwide. Its products are medicines developed through research and development to address various diseases, aiming to reach nearly 1 billion people. The company differentiates itself by large-scale investment in R&D, a global presence with a diverse workforce, and a clear mission to Reimagine Medicine, focusing on meeting the changing needs of patients. Its goal is to improve quality of life and extend life expectancy by delivering meaningful therapies through its research and development efforts.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1970

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