Manager, Drug Safety Systems

Our Stamford CT client is looking for a Manager, Drug Safety Systems.



Job Description:



* Manage the Cyclone Gateway and US electronic submissions via Argus Safety.

* Provide technical knowledge and expertise to meet the objectives of Drug Safety Systems.

* Provide the design, implementation, and support of computing infrastructures and applications in support of DSP objectives.

* Provide systems support to generate periodic reports, ISCH PSUR line listings, and other reports to be used in data analysis.

* Plan and implement dictionary upgrades and version management.

* Participate in the management, generation, and resolution of QC reports to ensure integrity of system safety and product data.

* Generate adhoc reports by using Cognos ReportNET; support transition of Crystal reports to Cognos REPORTNET; support queries from domestic and foreign regulatory authorities, Client's Law Department, healthcare professionals, and others.

* Provide production support and maintain configuration of Argus Safety and other DSP systems.

* Create documentation supporting changes to validated systems supported by Drug Safety Systems.

* Effectively communicate with the Drug Safety Systems team and other DSP and Purdue departments.

* Provide training as assigned to team and department personnel.



Requirements:



* 5+ years overall experience

* In-depth understanding of FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs

* In-depth understanding of ICH guidelines

* Understanding of MedDRA principles and hierarchy

* Oracle databases and PLSQL programming

* Thorough understanding and application of guidelines detailed in 21 CFR Part 11, including system validation requirements

* Report generation using Cognos ReportNET and Crystal

* Excellent verbal and written communication skills

* BS Computer Science or MS equivalent



This client will not sponsor. Must be US Citizen or Greencard.



Please send your resume in word format to selpern@celerityts.com with salary requirements.