Sr Business Analyst (Pharmacovigilance & AI Systems)

📋 Description

• Lead requirements engineering: Elicit, document, review, and maintain User Requirements
• Develop clear requirements documentation: Create and maintain process maps, data-flow diagrams
• Maintain requirements traceability: Build and manage a Requirements Traceability Matrix linking
• Coordinate stakeholder reviews and change control: Work with pharmacovigilance operations, Quality
• Specify literature screening and adverse event intake workflows: Define requirements for literature
• Support signal management and regulatory reporting: Translate business needs into requirements for

🎯 Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, medicine, computer science, or a related
• At least 6 years of experience in pharmacovigilance or pharmacovigilance systems, including a
• Demonstrated experience authoring URS and FRS documentation for pharmacovigilance or other
• Working knowledge of at least four relevant areas, such as literature monitoring, ICSR intake and
• Hands-on familiarity with at least one commercial safety database, such as Oracle Argus
• Solid understanding of 21 CFR Part 11, EU GMP Annex 11, data integrity principles including ALCOA+

🎁 Benefits

• Meaningful healthcare impact: Contribute to technology and processes that support medicine safety
• Collaborative environment: Work with multidisciplinary teams across pharmacovigilance, quality
• AI and technology exposure: Help define the next generation of AI-enabled systems in a highly
• Professional growth: Build expertise at the intersection of pharmacovigilance, business analysis
• Inclusive workplace culture: Join a team environment that values diverse backgrounds, mutual
• Innovation and continuous improvement: Contribute ideas, improve business processes, and help