Data Reviewer

new brunswick, New Brunswick, Canada • Posted March 23, 2026

Job Type: Full-time

Location: new brunswick, New Brunswick

Posted: March 23, 2026

Category: Computer Occupations

Application Deadline: May 02, 2026

Role Description

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...
                

Interested in this role?

Click the button below to start your application for Data Reviewer at SUN PHARMA.

Apply Now