FORESIGHT PRACTICE AREA
VALIDATION ( 00i)
Involved in the complete life cycle of validating Pharmacovigilance / Drug Safety Adverse Event Reporting Systems at life sciences clients, which includes the analysis of Business and Functional requirements, assessing and mitigating Risks, planning for Validation approach and Test Strategy, developing Trace Matrix, developing and executing Validation Scripts, Defect Management and preparing Validation Summary Report.
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
EDUCATION AND OTHER QUALIFICATIONS
Previous computer systems validation experience, ideally with drug safety systems.