Associate Consultant - Pharmacovigilance Validation

Associate Consultant

Job Overview
The role will be responsible for driving the processes and making sure that deliveries are made following the correct processes. The resource will be acting as a quality gatekeeper.

Experience: 3+ years

Essential Functions
>Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace, related modules and Internal Products like PVQ, PVI, PVM etc.
>Be accountable for authoring Validation Plan, Test Plan, Traceability Matrix, Test Summary Report 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.

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.

Experience Level

Mid Level