
Posted 3 months ago
Principal Business Quality Analyst
AI Summary
Principal Business Quality Analyst who gathers and documents business, functional, and non‑functional requirements for software products in pharmacovigilance, runs client workshops, maps processes, and supports validation and testing activities.
About this role
General Purpose: Business/functional/application consultant on client/internal project, leading software product business, functional & application requirement analysis and documentation, supporting business process development, configuration, implementation, testing & validation of software applications.
Essential Duties & Responsibilities:
• Interact with client users and internal product owners to gather and author business, functional & non-functional requirements improvements for software products
• Running workshops and pilots with clients for product requirement and implementations
• Application installations, configurations and business process mappings for drug safety and pharmacovigilance clients
• Issue / bug prioritization & management in ticketing management system (JIRA)
• Formal system validation (OQs, PQs and IQs) and other SDLC documentation activities like authoring Test Strategy, Test Plan, Traceability Matrix, Test Summary Report, etc.
Minimum Requirements:
• Bachelor’s degree from a good college like B.Tech., B.IT or similar
• 5-8 years of total experience in software industry with at least 3 years in business and functional requirements analysis and authoring experience in pharmacovigilance domain.
• Medium level knowledge of SQL
• Knowledge of Drug Safety (Pharmacovigilance) domain
• Knowledge of a leading Drug Safety System like Argus Safety, ArigG, etc.
• Experience of system validation in Pharmacovigilance or Drug Safety domain
• Self-driven personality, ability and interest to guide junior team members
• Demonstrated proficiency in working on multiple projects and deadlines
• Strong problem solving and troubleshooting skills
• Good communication, presentation and documentation skills
Preferred Qualifications:
• Knowledge of periodic/aggregate reporting (PBRER, DSUR, PADER etc.)
• Business process mapping experience with clients
• Experience of working with enterprise software application
• Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence
Skills
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