NEWPosted 15 hours ago

Job ID: JOB_ID_3182103

Job Summary

We are seeking an experienced Argus Safety Consultant with strong functional knowledge of Pharmacovigilance processes and technical expertise in Oracle Argus Safety configuration, reporting, and system customization. The consultant will serve as a bridge between business stakeholders and technical teams to deliver scalable and compliant Argus solutions.

Key Responsibilities

Functional Responsibilities:

  • Gather, analyze, and document business requirements related to Pharmacovigilance.
  • Configure and support Oracle Argus Argus Safety modules including Case Processing, Workflows, Reporting, and E2B.
  • Perform system configuration such as Workflow configuration, Advanced Conditions, Business Configuration, Field Labels and Profiles.
  • Support aggregate reporting (PSUR, PBRER, DSUR).
  • Ensure compliance with global regulatory requirements (FDA, EMA, ICH).
  • Conduct UAT support and end-user training.

Technical Responsibilities:

  • Develop and support SQL queries for ad-hoc and aggregate reporting.
  • Develop and support for the CAB changes.
  • Perform Argus database understanding and troubleshooting.
  • Supports E2B R2/R3 configurations, Gateway configuration, Report scheduling and automation.
  • Experience in MedDRA and WHO Drug, AG Services, Refresh of the Lower Environments from Production Environment.
  • Work on system customizations including post-save customizations, Auto narratives, Custom fields.
  • Experience in managing and configuring the Interfaces for Argus with other systems.
  • Manage upgrades, patches, and validation documentation (IQ/OQ/PQ).

Required Skills

  • Strong hands-on experience in Oracle Argus Safety.
  • Good understanding of Pharmacovigilance lifecycle.
  • Proficiency in SQL, PL/SQL (Oracle DB preferred).
  • Experience in system configurations and customizations.
  • Knowledge of regulatory reporting standards (ICH E2B).
  • Experience with validation and compliance documentation.

Preferred Qualifications

  • Bachelors degree in Pharmacy, Life Sciences, IT, or related field.
  • 4+ years of experience in Argus Safety.
  • Exposure to cloud or infrastructure setup is an advantage.
  • Certification in Argus (preferred).

Soft Skills

  • Strong communication and stakeholder management skills.
  • Ability to translate business needs into technical solutions.
  • Problem-solving and analytical mindset.
  • Ability to work independently and in cross-functional teams.

Compensation & Location

Salary: $75 – $100 per year

Location: Princeton, NJ


Recruiter / Company – Contact Information

Recruiter / Employer: Scalable Systems Inc

Email: ankit.dubey@scalable-systems.com


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