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Safety Systems Manager – Argus Sme | Drug Safety Systems & Pharmacovigilance Technology

Fortrea
Fortrea
8+ years
preferred by company
Pune, India
1 May 12, 2026
Job Description
Job Type: Freelance Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Safety Systems Manager – Argus SME | Drug Safety Systems & Pharmacovigilance Technology

Job Location: Pune, India
Job Type: Full-Time
Department: Clinical Safety / Pharmacovigilance Systems / Drug Safety Technology
Work Mode: Office-Based
Experience Required: 8+ Years
Freshers Eligible: No
Industry: Pharmacovigilance / Clinical Research / Pharmaceuticals / Life Sciences / Healthcare Technology

Job Overview

We are hiring an experienced Safety Systems Manager – Argus Subject Matter Expert (SME) for a senior-level pharmacovigilance technology and drug safety systems role in Pune. This opportunity is ideal for professionals with deep expertise in Oracle Argus Safety, drug safety systems management, pharmacovigilance technology operations, system implementation, safety data migration, compliance management, and IT system governance.

The selected candidate will lead safety system implementation, support, configuration, release management, stakeholder coordination, vendor management, compliance oversight, and technical strategy for enterprise pharmacovigilance platforms.

This role is highly suitable for experienced professionals seeking leadership opportunities in drug safety systems, pharmacovigilance operations, safety technology management, and healthcare IT systems.

Key Responsibilities

  • Lead implementation, configuration, support, maintenance, and migration activities for drug safety and pharmacovigilance systems.
  • Serve as the Argus SME (Subject Matter Expert) for enterprise safety systems and technical operations.
  • Perform technical impact assessments for software enhancements, project proposals, and system change initiatives.
  • Develop standard and custom reports from safety systems for operational and compliance reporting.
  • Define and support IT system strategy, enterprise architecture review, compliance governance, and system evaluations.
  • Gather business requirements from stakeholders and ensure successful technical delivery in coordination with IT and vendor teams.
  • Support and train internal users, sponsors, and operational teams on safety systems functionality.
  • Collaborate with training teams to create safety systems learning materials and SOP documentation.
  • Provide expert guidance on MedDRA queries, safety front-end reporting, and pharmacovigilance data analysis.
  • Participate in data migration, validation, documentation, and system transition projects.
  • Manage system change control, release cycles, upgrades, and technical support escalations.
  • Monitor technical issue queues and resolve system failures within expected service timelines.
  • Conduct User Acceptance Testing (UAT) and document validation outcomes.
  • Lead complex global safety system projects involving multi-study and enterprise-level implementation.
  • Represent the systems team in client meetings, audits, internal governance discussions, and compliance reviews.
  • Drive process improvements across pharmacovigilance systems, reporting frameworks, and technical operations.
  • Oversee project planning, timelines, quality standards, budget management, and resource allocation.
  • Manage vendor relationships, service delivery expectations, and external stakeholder coordination.
  • Handle people management responsibilities including performance reviews, team mentoring, staffing, and professional development.
  • Ensure compliance with pharmacovigilance regulations, validated system standards, SOPs, and quality frameworks.

Required Qualifications

  • Bachelor’s degree in:
    • Life Sciences
    • Information Technology
    • Computer Science
    • Healthcare Technology
    • Related scientific or technical disciplines
  • Equivalent relevant professional experience may be considered.

Experience Requirements

  • Minimum 8+ years of experience in drug safety systems, pharmacovigilance technology, or clinical safety IT operations
  • Strong hands-on experience with:
    • Oracle Argus Safety
    • ARISg
    • Veeva Safety Systems
  • Prior leadership experience in system implementation, vendor coordination, and enterprise project delivery required
  • Freshers are not eligible