Drug Safety Specialist

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%

$80/hr

6  months