Job role: Oracle Argus Safety Administrator
Location: Morrisville,NC
Duration: 6 months+

General Requirements:

•Minimum 3-5 years of Oracle Argus Safety administration or Support experience.
•Should have completed at least two complete Oracle Argus setup and upgrade projects – 7.0 and above preferred
•Knowledge of Dictionary Upgrade MedDRA/WHODD preferred
•Should have knowledge of Oracle Argus System and Business Configuration
•Must have worked in a regulated requirement
•Knowledge of Cognos/OBIEEE/Argus Mart Preferred
•Ability to effectively provision, install/configure, operate and maintain Argus and vendor packaged software applications/packages.
•Minimum 5 years of experience in system design, administration, application software, and operations required.
•Ability to research and develop solutions to new or unknown Argus and Database issues
•Able to work independently, manage time and complete tasks within deadlines
•Proactive, self-motivated, detail-oriented and organized.
•Assist project teams with technical issues, including definition of needs, benefits, technical strategy, technical analysis and design, support of operations staff in executing, testing, and rollout of solutions.

Technical Requirements:

•Good knowledge of Oracle Argus Safety, IIS web servers and Windows servers
•Knowledge of Windows server operating systems and environments
•System Validation knowledge – IQ/OQ/PQ
•Solid experience with Application, SQL Script deployments
•Previous experience writing simple automation scripts using any language (VBScript, PowerShell, etc.) preferred
•Understanding of local and wide area networks, protocol and simple network troubleshooting

Qualifications:
•Solid technical background and experience working with Oracle Safety Argus Suite
•Possess fine-tuned analytical and troubleshooting skills and/or programming experience
•Should have worked on any ticketing tool
•Possess system deployment/implementation expertise; preferably in a regulated environment
•Possess good organizational and communication skills
•Knowledge of the clinical drug development industry, procedures/processes, and regulatory standards desirable
•Proficiency in related, underlying technologies, including SQL, Oracle, XML, and integration technologies and standards
•Possess a working knowledge in software development tools, practices and lifecycle methodologies
•Experience with producing documentation in a regulatory-compliant environment
•Ability to handle multiple tasks
•Bachelors degree in technical domain or Bachelors degree and applicable technical education

Minimum Required Education and Experience
•5+ years of experience in IT support and development
•Have worked for a Pharma and or CRO at least for 3 or more years
•Bachelor’s degree in IT or equivalent
•Familiarity with FDA and EMA Drug and Device Safety Reporting regulations desirable
•Familiarity and Experience with Agile methodology and Scrum
•ITIL Certification is preferred
Key Skills: