Consulting

Business Quality Analyst (Senior)
Princeton, NJ, US, Japan, Noida & Bangalore, India
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Date-3rd June,2020

Job Status: Full Time

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 configurations and business process mappings for drug safety and pharmacovigilance clientsIssue / 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
  • 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 signalling
  • 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%