Senior Business Analyst, Pharmacovigilance
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Job Summary
To enhance pharmacovigilance and AI systems, the full-time Senior Business Analyst, Pharmacovigilance will manage requirements engineering, stakeholder collaboration, and regulatory compliance, while working remotely from Delhi, India.
Key responsibilities
- Elicit, document, and maintain user requirement specifications (URS) and functional requirement specifications (FRS) for various platform modules
- Collaborate with cross-functional teams to support user acceptance testing (UAT) and prepare functional documentation
- Define and specify requirements for AI systems, ensuring compliance with regulatory standards and quality management systems
Required qualifications
- Bachelor's degree in life sciences, pharmacy, nursing, medicine, computer science, or a related field
- 6+ years of experience in pharmacovigilance or PV systems, with at least 3 years in a business analyst or systems analyst role
- Proven experience in authoring URS and FRS for regulated life-sciences systems
- Solid understanding of 21 CFR Part 11, EU GMP Annex 11, and GDPR
- Practical knowledge of AI systems and their application in regulated environments
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