Data Reviewer () pharma

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 worksheets and highlight noteworthy/ major/ critical observations on CDRO certifications
- Completes the audit tasks within the specified timeframe without compromising the quality of the audit and archives all documents in a closed electronic system
- Collates audit findings in the audit comments log
- Performs any other responsibilities which are required as assigned by the manager/s depending on departmental needs
- Completes all training requirements as per Learning Management System (LMS) and as per Safety
- Adheres to the Safety and Health Program and associated plans.

Work Conditions:

Corporate office environment

Laboratory environment – QC and ARD

Manufacturing / Production setting

The ODR data reviewer will be mainly working in an office workplace as the job requires review of copies of reference documents. Exposure to laboratory/ manufacturing environments is at a minimum only and only expected when the ODR data reviewer needs to physically view any concerns or needs to have a face-to-face discussion with the stakeholders.