Description
Responsibilities- Develops and supports key metrics analysis and reporting for the Quality Group.
- Generates quality metrics using specific systems/applications.
- Uses strong technical/analytical skills to produce accurate and timely reports.
- Provides ongoing analysis of data resulting from the quality review of regulatory submissions.
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. Knowledge of adverse event report case processing activities so as to ensure the accuracy of ICSR and aggregate data needed. Must have knowledge of global regulatory requirements relative to pharmacovigilance, in particular regulatory submission requirements. Demonstrated analytical skills and attention to detail required. Demonstrated strength in verbal/written communication and interpersonal skills; team player. Demonstrated organizational skills. Experience in collecting, analysing, and presenting data and recommendations to management needed. Must have experience in developing metrics, reporting and analysis. Advanced skills in Microsoft Excel required: V-lookups, pivot tables and graphs. Intermediate skills in PowerPoint (PowerPoint: update, create and edit presentations) required.
Must have expertise/expert skills in the following:
MS Excel, MS Outlook, MS PowerPoint, MS Word, Quality Assurance, and Regulatory Documentation.
Synectics is an Equal Opportunity Employer.