Description
RESPONSIBILITIES:- Candidate will be dedicated to developing and supporting key metrics analysis and reporting for the Quality Group.
- He/she will be responsible for generating quality metrics using specific systems/applications.
- Also responsible for providing ongoing analysis of data resulting from the quality review of regulatory submissions.
4-7 years Outlook, PowerPoint, Word, Quality Assurance, Quality Documentation, Regulatory Documentation, Data Manipulation and Documentation required.
- Experience in developing metrics, reporting and analysis.
- Experience in safety/pharmacovigilance/risk management in the pharmaceutical industry.
- 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.
- Demonstrated analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills; team player.
- Demonstrated organizational skills.
- Experience in collecting, analysing, and presenting data and recommendations to management.
- Advanced skills in Microsoft Excel required: Vlookups, pivot tables and graphs.
- Intermediate skills in PowerPoint (update, create and edit presentations).
- Candidate must have strong technical/analytical skills to produce accurate and timely reports.
- BS degree; scientific background; healthcare degree/experience preferred.
- Experience in quality control and/or quality assurance of regulatory submissions/aggregate reports within the pharmaceutical industry highly desirable.