Hello Business Associates,
Please go throught the requirement and forward your consultant resumes asap.
Safety Informatics Manager/Senior Systems Analyst/Technologist – Job Description
POSITION: Safety Informatics Manager/Senior Systems Analyst/Technologist
SUPERVISOR: Sr. Manager/Associate Director, Drug Safety Systems
DEPARTMENT: Worldwide Drug Safety Surveillance
PREREQUISITES:
1. Minimum of B.A./B.S., international equivalent, in relevant scientific discipline.
2. Eight (8) years of relevant experience, including training.
3. Three (3) years of drug safety systems experience preferred.
RESPONSIBILITIES:
1. Ensure appropriate business strategies and objectives for Global Safety Systems by maintaining awareness of IS technology and trends as well as business needs of Celgene Global Safety.
2. Participate in system management meetings.
3. Execute technical implementation and maintenance of new or existing safety systems:
• Application technical maintenance
• Analyzing and upgrading existing system logic
• Participating as technical expert
• Analyzing and evaluating existing or proposed systems
• Support safety data query activities
• Develop data specific systems (write code)
• Support IQ/OQ activities for application installation
• Execute gap analysis and implement upgrades
4. Execute system maintenance activities:
• Upgrades
• System administration
• Trouble-shoot, debug, implement corrective technical solutions
5. Participate in system validation activities:
• Create, review, sign, and distribute validation documents
• Participate in validation testing
6. Participate in the use of programming and design techniques that ensure adherence to software development standards.
7. Perform sophisticated ad hoc data outputs from safety systems:
• Programming and executing scripts
• Clean and verification of data
8. Perform data administration:
• Verify, clean-up, reconcile, and migrate
• Perform MedDRA legacy conversion and upgrades
9. Collaborate with other departments including Corporate IT as appropriate.
10. Participation in the implementation of data warehouse technology.
SKILLS/KNOWLEDGE REQUIRED:
Proficiency of MS Office suite (Word, Excel, PowerPoint).
Proficiency of Oracle database, Oracle Developer, standard programming languages (SQL & PL/SQL)
Proficiency of Business Objects, Java
Safety reporting applications: Detailed knowledge of at least one data management system such as ARISg and modules.
Understanding of software development lifecycle development standards.
Understanding of data warehouse concepts.
Familiarity with SAS data sets and conversion procedures a plus.
Knowledge of FDA/ICH and global regulatory requirements for worldwide Pharmacovigilance and industry standard practices regarding data management.
Thanks & Regards,
Vijay B Yasaram | E-mail
Thoughtwave Software and Solutions, Inc. | Web URL
Desk: 630-780-3498; Fax: 630-689-5746
G-Talk: Vijaybhasker321
If you would like to be removed, send a separate email to vijayg@thoughtwavesoft.com
