The job involves the complete life cycle of validating Pharmacovigilance* / Drug Safety Adverse Event Reporting Systems at Pharmaceutical companies. The validation lifecycle includes capturing Business and Functional requirements, developing Trace Matrix, assessing Risks, developing and executing Validation Scripts and preparing Validation Summary.
Technical Skills
⢠Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules. This includes preparation of:
⢠User Requirements Specifications (URS)
⢠Functional Requirements Specifications (FRS)
⢠Development of validation scripts â Operational, Process and Installation Qualification (OQ/PQ/IQ)
⢠Execution of OQ/PQ/IQs Validation Summary Report
⢠Accountable for specific application deliverables such as validation master plan, user requirements, functional specifications, risk assessment analysis, validation protocols (IQ, OQ
Job Description
The job involves the complete life cycle of validating Pharmacovigilance* / Drug Safety Adverse Event Reporting Systems at Pharmaceutical companies. The validation lifecycle includes capturing Business and Functional requirements, developing Trace Matrix, assessing Risks, developing and executing Validation Scripts and preparing Validation Summary.
Technical Skills
⢠Provide application validation expertise on Adverse Event Reporting products including Argus Safety, ArisG, Oracle AERS, Clintrace and related modules. This includes preparation of:
⢠User Requirements Specifications (URS)
⢠Functional Requirements Specifications (FRS)
⢠Development of validation scripts â Operational, Process and Installation Qualification (OQ/PQ/IQ)
⢠Execution of OQ/PQ/IQs Validation Summary Report
⢠Accountable for specific application deliverables such as validation master plan, user requirements, functional specifications, risk assessment analysis, validation protocols (IQ, OQ, PQ), trace matrix and validation summary report.
⢠Working with the product development and engineering teams of product vendors to support implementation as well as resolve product issues.