Company Profile:
RxLogix is a leading global Pharmacovigilance consulting firm involved in product development and drug safety consulting services to various pharmaceutical, biotech, CRO’s and medical device companies of all sizes to define their business processes. We cater end to end solutions and analytics and reporting tools for implementing drug safety systems which helps them to run their business efficiently by meeting their regulatory compliance of various regulatory authorities and strategizing their business goals.
General Purpose: Business/functional/application consultant on client/internal project, providing support in software product testing & validation, business process development, configuration & implementation of software applications.
Essential Duties & Responsibilities:
Provides business, functional, and technical support with all aspects of application testing & consulting services, which include:
- End to end system testing activities
- Knowledge of Japanese language
- Understanding of application and business process for translating into test scenarios
- Formal system validation (OQs, PQs and IQs) and other SDLC documentation activities like authoring Test Script, Traceability Matrix, Test Summary Report, etc.
- Authoring and executing automation/manual test scripts
- Issue / bug management in ticketing management system (JIRA)
- Authoring business / functional requirements & improvements for the software products
- Configurations and business process mappings for drug safety and pharmacovigilance clients for Japan
- Knowledge of SQL is needed
- Knowledge of Testing methodologies and RDBMS
Minimum Requirements:
- Tech, B.E./MCA/M.Sc. (Tech/computer Science) etc
Preferred Qualifications:
- Experience with MS Office (Excel, PowerPoint, Word), SharePoint.
- Experience with Oracle Database
- SQL knowledge
- Japanese Language Certification (N3/N2)
Skills Required
- Bachelor's degree in Tech, B.E./MCA/M.Sc. in Computer Science
- Knowledge of Japanese language
- Knowledge of SQL
- Understanding of testing methodologies
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.
