Principal Business Quality Analyst

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

• Experience: 3+ years
• Seniority: Mid Level
• Education: Bachelor's degree required
• Languages: English