Argus Database Power User

4 weeks ago

Boston, United States iVigee Full time

iVigee, a leading pharmacovigilance services and technology company focused on creating simple, powerful, and elegant drug safety solutions that span the entire drug safety life cycle, is seeking a new team member for the position of Argus Database Power User / System Analyst. The ideal candidate should be based in Boston Metro area and/or East Coast.

 

We combine years of experience with the latest innovative AI technologies to create the ‘instant pharmacovigilance department’, deployable anywhere, on-demand.

 

Our teams support clients around the world with progressive pharmacovigilance and data management requirements from our strategic bases in Europe and the US.

 

iVigee: Simple. Powerful. Elegant. 

 

Purpose of the job position

The role is responsible for the efficient operation, support, and optimization of the Oracle Argus safety database. This includes system configuration, user support, troubleshooting, and generating critical reports for regulatory submissions and internal decision-making. The role supports pharmacovigilance operations by ensuring data accuracy and compliance with regulatory requirements and collaborating with the Head of Argus Database Systems and other stakeholders.

 

MAJOR TASKS AND RESPONSIBILITIES:

System Administration:

  • Perform system configuration and administration of the Oracle Argus database.
  • Assist with upgrades, patches, and system maintenance.
  • Monitor performance, resolve issues, and ensure timely processing of adverse event data.


Report Generation & Analysis:

  • Generate routine and ad-hoc reports from the Argus database, including regulatory reports (e.g., Periodic Safety Update Reports, DSURs).
  • Provide safety data exports for internal analysis and external regulatory submissions.
  • Customize and automate reports to meet the needs of pharmacovigilance, regulatory, and management teams.


User Support & Training:

  • Provide day-to-day support for pharmacovigilance users, addressing system-related issues.
  • Conduct training sessions and create user documentation on Argus functionalities.

 

Collaboration & Process Improvement:

  • Work with IT and other teams to improve workflows and system performance.
  • Participate in system enhancement projects and identify opportunities for optimization.

 

Compliance & Security:

  • Support system audits and ensure compliance with global pharmacovigilance regulations (GVP, FDA, EMA).
  • Implement security measures and manage access controls in the Argus system.

 

SPECIFIC REQUIREMENTS FOR THE POSITION:

Education

  • Bachelor’s degree in Computer Science, Life Science, Information Technology, or related field.

Experience

  • 5+ years of experience with Oracle Argus database or 10+ years of work experience in lieu of an IT or Computer Science degree
  • Expertise in Argus administration, implementation, configuration, data migration and report generation
  • Experience with the validation of GxP regulated systems specifically, the Oracle Argus.

Special skills

  • Strong understanding of pharmacovigilance processes and global regulatory requirements.
  • Technical proficiency in SQL and report generation.
  • Attention to detail with experience in data integrity management.
  • Excellent problem-solving and troubleshooting abilities.
  • Strong communication skills for working with technical and non-technical users.
  • Ability to manage multiple tasks and deliver high-quality reports under tight deadlines.
  • Collaborative team player with a proactive approach.

Language skills

  • Strong oral and written English communication skills

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