Safety Systems Analyst

Position Summary:Major Duties and Responsibilities (including supervising others):1. Provides programming support for epidemiology, bio-statistics, medical evaluation and risk management functions. 2. Assists safety monitors as required resolving technical problems, data discrepancies and generation of reports. 3. Contributes as a core project team member in the implementation of the new information system tools (Example: signal detection software) for product safety. 4. Responds in a timely manner to urgent requests from product safety personnel for safety data reports necessary to answer safety queries originating from Regulatory Authorities or healthcare professionals. 5. Works with the computer validation and the IT department in preparation and/or testing of the validation test scripts. 6. Provide programming and validation support for data migration in multiple formats (E2B, Oracle, SAS transport, Excel.) 7. The primary areas of responsibility will be performing system administrator support and implementation activities for safety systems applications, especially Adverse Reaction Information System (ARISg.) 8. Provide direct system support in account creation, screen changes, system configuration, and maintenance of the reference libraries and system upgrades/updates of ARISg. 9. Works with IT with maintenance and operation of the electronic submission gateway and assists product safety and regulatory operations personnel with electronic submissions. 10. Assists in development of Work Practice Documents and SOPs related to the administration and use of the Safety Systems. Requirements/Qualifications:Education: Bachelors degree (minimum) in the computer sciences or related scientific engineering fields.Experience: A minimum of 2 years experience in the area of clinical data management. Should have experience in development of reports using third-party reporting tools such as Business Objects. Should have strong SQL and PL/SQL language skills. Work experience with Oracle RDBMS is highly desirable. Prior experience in Pharmaceutical/Biotech industry is desirable. Ideal candidate will possess excellent computer skills, a familiarity with database management, strong interpersonal, communication and organizational skills. Knowledge of Pharmacovigilance processes, Electronic submissions, EudraVigilance database, FDA, ICH regulations and SAS programming is a plus.Special Skills/Abilities: Ability to work in a team environment. Job Complexity: Works on information systems related problems in drug safety business area. Should apply logical thinking in solving complex system issues. Should be able to effectively communicate with the business users as well as the IT department.Supervision: Receives direction from the Head of Safety Systems on complex issues. Routinely works with Head of Safety Systems. Expected to work independently while interacting with Product Safety, IT application development, SAS programming and the application vendor in trouble shooting problems. MedImmune, Inc. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law. Job Title: Safety Systems Analyst Company:  MedImmune Inc. Location:  Gaithersburg, MD 20878 Status:  Full Time, Employee Job Category:  IT/Software Development Company: MedImmune Inc.