Document & Data QC Consultant

RESPONSIBILITIES

- Conducts QC review (including verification of data against approved sources) of document deliverables including PSURs, RMPs, responses to regulatory authorities, labels, submission components (SCS, SCE, etc) ensuring accuracy and internal consistency.
- Provides ongoing analysis of data resulting from the quality review of document deliverables.
- Collaborates with colleagues in generation of document review metrics.

SKILLS:

BS degree required; scientific background; healthcare degree/experience preferred. Experience in safety/pharmacovigilance/risk management in the pharmaceutical industry needed. Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry highly desirable. Must have knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data. Knowledge of global regulatory requirements relative to pharmacovigilance, in particular regulatory submission requirements required. Demonstrated analytical skills and attention to detail needed. Excellent in verbal/written communication and interpersonal skills required; must be a team player. Demonstrated organizational skills also needed. Must have four to seven (4-7) years of experience in the following: Quality Control, Regulatory Documentation, and Regulatory Experience