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Safety Systems Specialist (Argus Safety Consultant)

Fortrea
Fortrea
2+ years
preferred by company
10 Jan. 14, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Systems Specialist – Argus Safety Consultant

Location: Bangalore, India
Work Mode: Hybrid
Employment Type: Full-Time
Application Deadline: January 25, 2026
Job Requisition ID: 26130


Job Overview

We are hiring a Safety Systems Specialist (Argus Safety Consultant) to support the implementation, configuration, migration, and ongoing maintenance of pharmacovigilance safety systems. This role is critical in ensuring reliable safety data processing, regulatory compliance, and seamless system operations for both internal stakeholders and external clients.

The ideal candidate will have hands-on experience with Oracle Argus Safety, system configuration, UAT, and safety data migrations within a regulated pharmacovigilance environment.


Key Responsibilities

  • Support end-to-end implementation, configuration, maintenance, and migration of safety systems, primarily Oracle Argus Safety.

  • Perform project-specific system configurations and document system changes in line with validated processes.

  • Develop, validate, and maintain standard and ad hoc safety reports from Argus Safety.

  • Execute routine and ad hoc data extractions including PSURs, DSURs, and periodic listings.

  • Participate actively in safety data migration activities, including validation documentation and reconciliation.

  • Conduct User Acceptance Testing (UAT) and complete all associated testing documentation.

  • Provide system support, issue resolution, and ticket management, escalating critical issues when required.

  • Monitor system mailboxes and proactively resolve system failures within defined timelines.

  • Support end-user and sponsor training on safety system functionality and best practices.

  • Assist with system upgrades, enhancements, and change management activities.

  • Ensure adherence to SOPs, validation standards, and global pharmacovigilance regulations.

  • Train and mentor team members on both technical and functional aspects of safety systems.

  • Collaborate closely with PV operations, IT, and compliance teams to ensure system reliability.

  • Perform additional responsibilities as assigned by management.


Qualifications & Experience

Education

  • Bachelor’s degree in Life Sciences, Information Technology, Computer Science, or a related discipline

  • Equivalent relevant experience may be considered in lieu of formal education

Experience Required

  • Minimum 2+ years of hands-on experience working with Oracle Argus Safety

  • Experience in Argus system configuration, upgrades, and validation

  • Proven experience in User Acceptance Testing (UAT) within validated systems

  • Experience supporting pharmacovigilance system operations or application support roles

  • Exposure to validated document management systems and regulated environments


Technical & Professional Skills

  • Strong working knowledge of Argus Safety architecture and workflows

  • Understanding of safety data migration, reconciliation, and reporting

  • Familiarity with PV regulations and compliance requirements

  • Proficiency in Microsoft Office applications

  • Basic understanding of system integration concepts

  • Strong attention to detail with excellent documentation skills

  • Ability to manage multiple priorities and work effectively in a fast-paced environment

  • Strong written and verbal communication skills

  • Team-oriented mindset with the ability to support peers and stakeholders


Preferred Qualifications

  • Clinical or pharmacovigilance background working with safety or clinical systems

  • Working knowledge of SQL

  • Experience with ticketing and incident management tools


Work Environment

  • Hybrid office-based work model

  • Extensive computer usage in a regulated systems environment


Why This Role

This role offers an opportunity to build deep expertise in pharmacovigilance systems, Argus Safety consulting, and global safety operations, supporting critical safety processes that directly impact patient safety and regulatory compliance worldwide.


Apply now on thepharmadaily.com to advance your career in drug safety systems, Argus Safety consulting, and pharmacovigilance technology operations.