Description
Responsibilities- Conduct 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.
- Provide ongoing analysis of data resulting from the quality review of document deliverables.
- Collaborate with colleagues in generation of document review metrics.
- 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 of regulatory submissions/aggregate reports within the pharmaceutical industry highly desirable.
- 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.
SKILLS
Demonstrated analytical skills and attention to detail. Demonstrated strength in verbal/written communication and interpersonal skills; team player. Demonstrated organizational skills. 4-7 years of experience in the following: Quality Control, Regulatory Experience, and Regulatory Documentation
Synectics is an Equal Opportunity Employer.