The Data Reviewer, Office of Data Reliability (ODR) is accountable for critical review of pre-submission applications ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission applications by using department SOPs and exhaustive audit checklists to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.
Area Of Responsibility
Ensures compliance with cGMP/cGLP and good documentation procedure during the review process Audits regulatory pre-submission documents from the manufacturing and quality units within the purview of ODR checklist Communicates any audit comments/ observations/ findings to respective stakeholders and assesses acceptability/ appropriateness of responses Informs the manager/s and Chief Data Reliability Officer immediately of any critical data integrity issues or data irregularity Reports all audit finding in the ODR audit works...