Senior Safety Data Analyst (440633)
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POST DATE 9/12/2016
END DATE 10/9/2016
Fort Lee, NJ
JOB DESCRIPTIONJob Description:
OVERVIEW:Reporting to the Director of Informatics, this position will primarily deal with internal customers (e.g. PVRM physician s), and act as the database ambassador of information. The individual will be responsible for contributing to external customer teams (e.g. Regulatory Affairs) in the compilation of Annual Reports. Essential Functions:Be able to create advanced level reports utilizing Cognos Report Studio and Framework Manager, SQL, Argus reporting, Adobe Acrobat, MS Excel and other tools as needed for aggregate reporting, safety data surveillance, data mining and risk management. 40%Be experienced in Pharmacovigilance safety data processing and Oracle s Adverse Event Reporting System (Argus) or other similar application for the tracking of drug safety data to contribute to decisions for report design and testing of system configurations. 20%Plans, coordinates and executes ODRM/RBM deliverables for multiple projects/ studiesSupport in documentation, testing and validation of reports and functionality of Argus and Cognos. 20%Analyze medical surveillance data using epidemiological or statistical methodology and provide reports or data that will assist in the evaluation of potential safety signals. 10%Contribute at team and cross-functional meetings on specifications design, project plans and request and project prioritization. Contribute to process improvement and SOP and WI writing. 10% Education/Experience Requirements:5-7 years of relevant work experience, preferably within the pharmaceutical industry. This experience would include work with commercially available, Oracle-based, validated clinical and/or safety applications. Experience working with validated safety applications is preferred.Understanding of Oracle business applications and reporting tools is essential, including web-based and client-server applications running in an Oracle Argus, Internet/Intranet, Cognos environment. Familiarity with Crystal Reports, SAS and Empirica preferred.A fundamental working knowledge of CFR Part 11 is essential. The data analyst will have the ability to create complex data mining concepts effectively; will be skilled in decision making and sound judgment; have the ability to develop and complete assigned projects within scheduled timeframes.Solid understanding of Safety system operation and case processing. Familiarity with ICH and GxP guidance and regulations.Works effectively in a team environment and cultivates effective working relationships with peers, supervisors, vendors, and consultants including those with varying degrees of technical knowledge. Confidential Data/Compliance:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Client are carried out with the \\"best\\" industry practices and the highest ethical standards. Mental/Physical Requirements:Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary.Requires a high level of initiative and independence.Excellent written and oral communication skills required.Requires ability to use a personal computer for extended periods of time.
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