11+ years of experience in Life Sciences, Pharmacovigilance, and Drug Safety, I possess expertise in project management, requirements elicitation, change management, and system implementation. I am proficient in Agile methodologies, SDLC, and compliance/documentation within the Pharmacovigilance domain. I have a strong track record of successfully delivering projects, reducing operational costs, and ensuring regulatory compliance.Knowledge of CFR Part-11 Validation and preparing test scripts and review of Validation/Qualification Protocols IQ/OQ/PQ documentation, VP, VSR, Protocol Deviation, Risk Assessment as per the different business process of clientsKnowledge on E2B (R3 and R2) regulations and different regulatory reports like PSUR, DSUR MedWatch, CIOMS and Responsible for on-time delivery of projects Wide experience in Migrations, ARIS Total safety suite Installations, Application and Database Upgrade projects, performing customizations such as workflow changes, distribution rules\conditions, form changes, preparing new custom validations in ARISg\IRT application.Also, experience in Database Development, Implementations, Functional Enhancements, Administration, Post Implementation Support & MaintenanceWorked on Robotic Process Automation(RPA) projects using Uipath tool for automating the User access management and case processing in LSMV, ARISg application.Experience in Quality Assurance and Computer System Validation(CSV). Worked on End to end Product validation, conducting training sessions for Business users, Preparation/ review of validation deliverables such as VP, URS,FRS, Design Review,Test Plan,OQ,PQ, RTM,Defect management and VSR.Sound knowledge and thorough understanding of various software Development Life Cycle Models (SDLC), Software Test Life Cycle (STLC)Involved in all stages of testing such as Exploratory, Smoke, Functional, Integration, System, Compatibility testing to confirm all software requirements are fulfilledExperience in Pharmaceutical domain with Change Control Management testing and implementation of business applicationsExperience in Installations, Database Upgrade, Form changes, preparing new custom validations in agXchange IRT applicationSelf-motivated with Strong Communication Skills, Good team player and Quick learner.
