Description
Conduct QC review (including verification of data against approved sources) of document deliverables including responses to regulatory authorities, labels, and submission components, ensuring accuracy and internal consistency. Provide ongoing analysis of data resulting from the quality review of document deliverables. Collaborate with colleagues in generation of document review metrics.
SKILLS:
- 4-7 years experience in Quality Assurance of regulatory submissions/aggregate reports within the pharmaceutical industry. Knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data.
- Quality Documentation background.
- Solid experience in quality review of pharmacovigilance documents and reports submitted to regulators.
- Must have experience in a pharmaceutical environment with a strong background in Quality.
- Extensive experience with filing and auditing
- BS degree; scientific background; healthcare degree/experience preferred.
- Experience in safety/pharmacovigilance/risk management in the pharmaceutical industry.
- Experience in quality control and/or quality assurance
- Knowledge of global regulatory requirements relative to pharmacovigilance, in particular regulatory submission requirements.
- Demonstrated analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills; team player.
- Demonstrated organizational skills.