• Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules
• Be accountable for authoring Validation Plan, Traceability Matrix and Validation Summary Reports
• Requirements Analysis and Risk Assessment, Profiling and Mitigation
• Development, Execution, Approval and Monitoring of the Qualification (IQ, OQ, MQ, PQ scripts and protocols, results and reports) deliverables for GAMP Software categories
• Follow the cross-phase procedures and plans like Defect Management Plan, Change Control Procedure, Document Management Plan and Training Plan
• Closely work with clients and vendors to support implementation and resolve product issues
Essentials
• Prior experience of Argus validation
• Professional experience and strong knowledge with real time experience in Computer System Validation / Software Testing / System Implementation in the Life Sciences industry
• Excellent communication and inter-personal skills
• Commitment to excellence and high quality standards
• Versatility, flexibility, and a willingness to work within changing priorities
• International travel readiness, work hours that overlap global client location Time-zones
• Well versed with various SDLC models and Software Test life cycle and Defect Management Life Cycle
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.