Description
Conduct quality review of deliverables ensuring accuracy, internal consistency, uniformity, and compliance with regulatory commitments and expectations.
SKILLS:
Required Skills:
Demonstrated analytical skills and attention to detail required for conducting QC.
Demonstrated strength in written/oral communication.
Demonstrated organizational skills and ability to multi-task if necessary to meet established timelines.
Demonstrated understanding of technologies that support the business.
Demonstrated interpersonal skills and ability to work effectively as part of a team
Safety/risk management
Qualifications:
BS degree; scientific background; healthcare degree/experience preferred.
Experience in quality control (QC) and/or quality assurance (QA) of regulatory submissions within the pharmaceutical industry including Safety and Risk Management Plans and labels is required
Experience in pharmacovigilance preferred.