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 Required
- Bachelor's degree in B.Tech, B.IT, or similar
- 5-8 years of total experience in software industry
- At least 3 years in business and functional requirements analysis in pharmacovigilance
- Medium level knowledge of SQL
- Knowledge of Drug Safety (Pharmacovigilance) domain
- Experience of system validation in Pharmacovigilance or Drug Safety domain
What We Do
RxLogix is a one-stop-shop for all PV needs applying the most recent technology advances like machine learning, artificial intelligence, and best practice methodological approaches. After a thorough evaluation of commercially available signaling and analytical software vendors, the FDA selected RxLogix’s PV Surveillance Suite Platform, replacing their legacy FAERS signaling system. FDA has decided to implement RxLogix PV Surveillance Suite (Modules – PV Reports, PV Signal, PV Analytics, and PV Datahub) for advanced data analytics, signal detection, evaluation, signal management, and benefit-risk assessment. RxLogix experienced team of business and technology innovators work with Pharmacovigilance and Risk Management Professionals to help increase the compliance, productivity, and quality for the entire Drug Safety value chain thus ensuring patient safety. RxLogix highly values defiant bold thinkers entrenched in the world of science, medicine, and innovation. From a strategic perspective, RxLogix proactively seeks innovative solutions as preemptive strikes against second-rate thinking.
