Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety Systems Specialist

Fortrea
Fortrea
2+ years
Not Disclosed
Bengaluru, India
10 May 7, 2026
Job Description
Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Safety Systems Specialist
Employment Type: Full-Time
Work Mode: Hybrid
Location: Bangalore
Application Deadline: June 30, 2026
Job Requisition ID: 261413


Job Overview

This role involves supporting the implementation, configuration, migration, and maintenance of Pharmacovigilance (PV) safety systems.

You will work on ensuring safe, compliant, and efficient operation of safety databases and systems used in drug safety and regulatory reporting.

The role supports both internal teams and external clients, ensuring high-quality service delivery aligned with regulatory and safety standards.

Compliance is required with:

  • Health and Safety at Work Act 1974

  • COSHH Regulations 1989

  • EC Directives 1992/3

  • Company Health & Safety Manual


Key Responsibilities

1. PV Safety System Support

  • Support implementation, configuration, and migration of safety systems

  • Work on validated pharmacovigilance databases and tools

  • Ensure system stability and compliance with SOPs


2. System Configuration & Maintenance

  • Perform project-specific system configurations

  • Maintain documentation of system setups and updates

  • Update configurations based on requirement changes


3. Reporting & Data Handling

  • Develop standard and ad hoc reports from safety systems

  • Support data extraction activities such as:

    • PSUR (Periodic Safety Update Reports)

    • DSUR (Development Safety Update Reports)

    • 6-month safety listings


4. Data Migration & Validation

  • Participate in system data migration activities

  • Support migration documentation and validation processes

  • Conduct User Acceptance Testing (UAT) and document results


5. System Support & Issue Management

  • Handle ticket management and issue resolution

  • Escalate system issues when required

  • Monitor system mailboxes for failures and resolve issues promptly

  • Respond to user queries and support requests


6. Training & Change Management

  • Support end-user training and system education

  • Train team members on technical and functional system aspects

  • Assist in change management activities


7. Compliance & Quality

  • Ensure adherence to SOPs and regulatory requirements

  • Maintain high-quality documentation standards

  • Stay updated with pharmacovigilance regulations


8. Collaboration & Team Support

  • Work closely with PV systems and business teams

  • Provide peer support when required

  • Act as a team player in a regulated environment


Required Qualifications

  • Degree in Life Sciences or IT/Computer Science

  • Equivalent experience may be considered


Experience Required

  • Minimum 2 years of experience in:

    • Drug safety systems (e.g., Argus, ARISg, Veeva or similar)

    • Systems operations support roles

  • Experience with validated document management systems preferred

  • Knowledge of Microsoft Office tools


Key Skills Required

  • Strong attention to detail

  • Ability to multitask and prioritize work

  • Good written and verbal communication skills

  • Logical thinking and numerical accuracy

  • Basic understanding of system integration

  • Good keyboard and MS Office skills

  • Ability to handle ticketing systems


Preferred Skills

  • Clinical or pharmacovigilance systems background

  • Basic knowledge of SQL programming

  • Experience with IT/service desk or ticketing tools

  • Familiarity with PV regulatory environment


Work Environment

  • Hybrid (Office or Remote)

  • Structured, regulated, and SOP-driven environment

  • Collaboration with technical and pharmacovigilance teams