Senior Business Quality Analyst / Validation Lead

Job description

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 configurations and business process mappings for drug safety and pharmacovigilance client's 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
• 5-10 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
• Understanding of 21 CFR Part 11 guidelines
• 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.) and signaling
• Business process mapping experience with clients
• Experience of working with enterprise software application
• Working knowledge and experience of Oracle Database, Agile/JIRA, Confluence

Travel Expectations:
0-25%