Drug Safety Specialist

SmartRecruiters, Inc.; Marlborough (MA); On-site; USD 94,000 - 127,000; Full time

Job summary

Global Channel Management in Marlborough, MA seeks a Drug Safety Specialist with 5-7 years in Cognos report development and project management, preferably in the pharmaceutical industry. The role emphasizes working with validated applications, Oracle-based reporting tools, and Argus environments to support safety reporting.

You will build advanced Cognos reports, manage internal and external projects, support pharmacovigilance data processing in Argus, and contribute to documentation, testing

Qualifications

• 5-7 years in Cognos report development and project management, preferably within the pharmaceutical industry.
• 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 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.

Responsibilities

• 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.
• Manage IM internal and external projects and vendors. Setup projects plans, ensure adherence to timelines.
• 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.
• Support in documentation, testing and validation of reports and functionality of Argus and Cognos. Contribute to process improvement and SOP and WI writing.

Skills

Cognos reporting

Project management

Pharmacovigilance

Tools

Oracle business applications

Crystal Reports

SAS

Empirica

Argus

Cognos tools

Job description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.

Qualifications

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

Drug Safety Specialist requires:

• 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