JVT Advisors

Argus Safety Analyst & Programmer

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Location: Waltham, Massachusetts 02451
Employment Type: Contract

Job Description

Contract Length: 6 months

 

Job Summary: This individual supports the DSPV Systems & Analytics team in database validation and configuration activities, and in the fulfillment of data requests.

 

Responsibilities:

  • Collaborate cross functionally to understand and analyze the impact and scope of project.
  • Collaborate with the safety system hosting vendor to develop and implement system changes as needed (e.g., product configuration, protocol configuration, workflow changes, user access changes, etc.).
  • Identify and respond to issues concerning Safety System and application components (Argus Safety, Analytical Tools, etc.).
  • Provide technical support and implement solutions for system configuration changes (e.g., enhancements, new functionality requests, and troubleshooting),
  • Contribute to process improvements related to the DSPV safety system.
  • Organize data using Excel to create tables and charts to facilitate data analysis for aggregate data review as well as for signaling activities
  • Development, Review, Execution, and Monitoring of the system qualification ( IQ, OQ, PQ scripts and protocols, summary reports) deliverables
  • Responsible for technical issue resolution including diagnosis of problem, recommendations for workarounds, and defect correction.
  • Analyze, designs, implement enhancements/changes to system.

 

Requirements:

  • Strong knowledge and experience with the safety system (Argus Safety) including PV operation, technical, and analytical skills.
  • Must be proficient in Microsoft Excel, Word, and PowerPoint.
  • Must have proficiency in Oracle SQL/PL SQL and query tools
  • Strong knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.
  • Must have experience with MedDRA and WHO Drug coding dictionaries.
  • Proficiency with use of Adobe Acrobat (Reader and Writer), Microsoft XL and Microsoft Word.
  • Minimum Bachelor’s degree in life sciences, computer science, or health-related field.
  • 5-6 years of experience supporting a Drug Safety database in a pharmaceutical company, or equivalent.

 

Jared Potter

Recruiter

He's a natural people person.

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