Senior Safety System Analyst

* Execute technical implementation and maintenance of new or existing safety systems
Analyze and upgrade existing system logicAnalyze and evaluate existing or proposed systemsSupport safety data query activitiesDevelop data specific systems (write code)Support IQ/OQ activities for application installationExecute gap analysis and implement upgradesTrouble-shoot, debug, and implement corrective technical solutions
* Participate in validation testing
Create, review, sign, and distribute validation documentsParticipate in the use of programming and design techniques that ensure adherence to software development standards
* Perform sophisticated ad hoc data outputs from safety systems
Program and execute scriptsClean and verify data
* Perform data administration
Verify, clean-up, reconcile, and migratePerform MedDRA legacy conversion and upgrades
* Collaborate with other departments including Operations, Quality Standards and Client Services as appropriate

Requirements:

Detailed knowledge of at least one safety data management system, such as Argus, Clintrace or ARISgProficiency in Oracle database, Oracle Developer, standard programming languages (SQL & PL/SQL)Proficiency in Business Objects Safety reporting applicationsProficiency in MS Office suite (Word, Excel, PowerPoint)Understanding of software development lifecycle development standardsUnderstanding of data warehouse conceptsFamiliarity with SAS data sets and conversion procedures a plusFamiliarity with FDA/ICH and global regulatory requirements forworldwide pharmacovigilance and industry standard practices regardingdata management