Drug Safety Specialist

Job Description

Qualifications

Drug Safety Specialist  needs 5-7 years in Cognos report development and project management, preferably within the pharmaceutical industry.

Drug Safety Specialist requires:

• Pharmacovigilance, project management
• Experience working with validated applications is preferred.
• Understanding
  of Oracle business applications and reporting tools is essential,
  including web-based and client-server applications running in an Oracle
  Argus, Internet/Intranet, Cognos environment.
• Familiarity with Crystal Reports, SAS and Empirica preferred.
• working knowledge of CFR Part 11 is essential.
• Familiarity with ICH and GxP guidance and regulations.

Drug Safety Specialist duties are:

• Be
  able to create advanced level reports utilizing Cognos, SQL, Argus
  reporting, Adobe Acrobat, MS Excel and other tools as needed for
  aggregate reporting, safety data surveillance, data mining and risk
  management. 30%

• Manage IM internal and external projects
  and vendors. Setup projects plans, ensure adherence to timelines.
  Contribute at team, cross-functional, external and vendor meetings on
  specifications gathering, project plans, request. 30%

• Be
  experienced in Pharmacovigilance safety data processing and Oracle's
  Adverse Event Reporting System (Argus) or other similar application for
  the tracking of drug safety data to contribute to decisions for report
  design and testing of system configurations. 20%

• Support
  in documentation, testing and validation of reports and functionality
  of Argus and Cognos. Contribute to process improvement and SOP and WI
  writing.20%

• 
  

Additional Information

$80/hr

6  months