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Safety Systems Specialist

Fortrea
Fortrea
0-2 years
3-5 LPA
Bangalore, India
10 May 5, 2026
Job Description
Job Type: Hybrid Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc., Lifesciences graduate 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

Safety Systems Specialist – Pharmacovigilance Systems | Hybrid Opportunity | Bangalore

Job Location: Bangalore, India
Job Type: Full-Time
Work Mode: Hybrid
Application Deadline: June 30, 2026
Experience Required: Freshers or Minimum 2+ Years
Industry: Pharmacovigilance | Drug Safety | Clinical Research | Life Sciences | IT Systems


About the Role

A leading global healthcare and clinical research organization is hiring a Safety Systems Specialist to support pharmacovigilance safety systems implementation, configuration, migration, and operational support activities. This opportunity is ideal for professionals with expertise in drug safety databases, validated systems, pharmacovigilance operations, and safety data management.

The selected candidate will work closely with global PV teams, technical stakeholders, and end users to ensure efficient system functionality, regulatory compliance, and seamless safety data operations.

This role is highly suitable for candidates seeking career growth in:

  • Pharmacovigilance Systems

  • Drug Safety Operations

  • Argus Safety

  • ARISg

  • Veeva Safety

  • PV Technology Support

  • Clinical Safety Systems

  • Safety Database Administration


Key Responsibilities

  • Support safety system implementation, configuration, migration, and maintenance activities.

  • Perform project-specific configurations within pharmacovigilance safety systems.

  • Maintain accurate documentation for system configurations and change requests.

  • Generate standard and ad hoc safety reports from validated PV systems.

  • Conduct routine and custom data extraction activities including:

    • PSUR listings

    • DSUR listings

    • Six-monthly safety reports

  • Participate actively in safety database migration projects and related documentation.

  • Support system change management activities and end-user training programs.

  • Manage support tickets, troubleshoot system issues, and escalate critical concerns when required.

  • Perform User Acceptance Testing (UAT) and maintain validation documentation.

  • Monitor system mailboxes for failures, alerts, and operational issues.

  • Provide technical and functional training to team members.

  • Respond to stakeholder and user queries in a timely manner.

  • Ensure compliance with SOPs, GxP standards, and global pharmacovigilance regulations.

  • Collaborate effectively with internal and external cross-functional teams.


Required Qualifications

  • Bachelor’s degree in:

    • Life Sciences

    • Pharmacy

    • Biotechnology

    • Computer Science

    • Information Technology

    • Or related disciplines

  • Equivalent relevant industry experience may also be considered.


Required Skills & Experience

  • Minimum 2 years of experience in pharmacovigilance safety systems or validated clinical systems support.

  • Hands-on experience with drug safety databases such as:

    • Argus Safety

    • ARISg

    • Veeva Safety

    • Or equivalent PV platforms

  • Experience working with validated document management systems.

  • Good understanding of:

    • Safety system workflows

    • Data migration

    • System integration

    • Ticket management

  • Proficiency in Microsoft Office tools.

  • Strong communication, documentation, and problem-solving skills.

  • Ability to manage multiple priorities within deadlines.

  • Strong attention to detail and data accuracy.


Preferred Qualifications

  • Clinical systems or clinical research background.

  • Knowledge of SQL programming language.

  • Experience with ticketing and support applications.

  • Prior exposure to pharmacovigilance technology environments.


Work Environment

  • Hybrid working model.

  • Office-based and remote work flexibility available depending on business requirements.


Why This Role Matters

Safety Systems Specialists play a critical role in ensuring accurate safety data management, regulatory compliance, and smooth pharmacovigilance operations across global clinical and post-marketing environments. Professionals with expertise in PV systems and safety technologies are increasingly in demand across CROs, pharmaceutical companies, and healthcare organizations worldwide.