Business Quality Analyst (Senior)

General Purpose

The role involves acting as a business, functional, and application consultant on client and internal projects. The primary focus is on leading the analysis and documentation of business, functional, and application requirements for software products. This includes supporting business process development, configuration, implementation, and testing & validation of software applications, particularly in the pharmacovigilance domain.

Essential Duties & Responsibilities

• Requirement Gathering and Documentation: Engage with client users and internal product owners to gather and document business, functional, and non-functional requirements for software product improvements.
• Workshops and Pilots: Facilitate workshops and pilots with clients to understand product requirements and oversee implementations.
• Application Configuration and Business Process Mapping: Perform application configurations and map business processes, specifically for drug safety and pharmacovigilance clients.
• Issue Management: Prioritize and manage issues and bugs using a ticketing management system (such as JIRA).
• System Validation and Documentation: Conduct formal system validation activities, including Operational Qualification (OQ), Performance Qualification (PQ), and Installation Qualification (IQ). Author documentation such as Test Strategy, Test Plan, Traceability Matrix, and Test Summary Report.

Minimum Requirements

• Educational Background: Bachelor’s degree in a relevant field such as B.Tech., B.IT, or similar from a reputable institution.
• Experience: 5-8 years of experience in the software industry, with at least 3 years of experience in business and functional requirements analysis and documentation within the pharmacovigilance domain.
• Technical Skills:
  • Medium level knowledge of SQL.
  • Knowledge of Drug Safety (Pharmacovigilance) domain.
  • Familiarity with leading Drug Safety Systems like Argus Safety or ArigG.
• Regulatory Knowledge: Understanding of 21 CFR Part 11 guidelines.
• Personal Attributes: Self-driven with the ability to guide junior team members, strong problem-solving and troubleshooting skills, and the ability to work on multiple projects and meet deadlines.
• Communication Skills: Strong communication, presentation, and documentation skills.

Preferred Qualifications

• Advanced Domain Knowledge: Understanding of periodic/aggregate reporting (PBRER, DSUR, PADER, etc.) and signal detection.
• Business Process Mapping: Experience in business process mapping with clients.
• Enterprise Software Experience: Experience with enterprise software applications.
• Technical Tools Proficiency: Working knowledge and experience with Oracle Database, Agile/JIRA, Confluence.

Travel Expectations

• 0-25% travel required.

This role is ideal for a detail-oriented professional with a strong background in software development, pharmacovigilance, and system validation, who is keen on ensuring compliance and high standards in the development and implementation of drug safety systems.