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Safety System Coordinator Pharmacovigilance at Fortrea

Published on

Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Fortrea is seeking a Safety System Coordinator II to join our team in Bangalore. This role is critical in assisting with the implementation, configuration, migration, and support of safety systems. The ideal candidate will ensure the delivery of high-quality services to both internal and external clients while adhering to safety regulations and company standards.

If you have a background in Life Sciences or IT, along with experience in drug safety systems like Argus, ARISg, or Veeva, this could be the perfect opportunity for you.


About Fortrea

Fortrea is a global leader in clinical research and drug development solutions. We are committed to advancing healthcare by providing innovative and reliable services to pharmaceutical, biotechnology, and medical device companies. Our mission is to deliver high-quality results while ensuring the safety and well-being of patients worldwide.

At Fortrea, we value diversity, innovation, and collaboration. Join us to make a meaningful impact in the healthcare industry.

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Job Description

Key Responsibilities

  • Assist in the implementation, configuration, and migration of safety systems.
  • Conduct project-specific configurations in safety systems like Argus, ARISg, or Veeva.
  • Maintain and document system configurations based on initial requirements and changes.
  • Develop and document standard and ad hoc reports from safety systems.
  • Support and educate end-users and sponsors on system usage.
  • Perform routine and ad hoc data extraction (e.g., PSURs, DSURs, 6-monthly listings).
  • Participate in data migration activities and related documentation.
  • Manage tickets, resolve issues, and escalate system problems as needed.
  • Ensure compliance with SOPs and current pharmacovigilance (PV) regulations.
  • Conduct User Acceptance Testing (UAT) and complete required documentation.
  • Monitor and respond to mailbox queries and system failure alerts promptly.
  • Perform other duties as assigned.

Qualifications

Minimum Required:

  • Bachelor’s degree in Life Sciences, IT, or Computing.
  • At least 1 year of experience with drug safety systems (Argus, ARISg, Veeva).
  • Experience in systems operations support and validated document management systems.
  • Proficiency in Microsoft Office tools.
  • Knowledge of system integration.

Preferred Qualifications:

  • Clinical background with experience in clinical systems.
  • Understanding of SQL programming language.
  • Experience with ticket support applications.

Physical Demands/Work Environment

  • Office-based or remote work environment.

Why Join Fortrea?

  • Be part of a global team dedicated to advancing healthcare.
  • Work in a collaborative and innovative environment.
  • Opportunities for professional growth and development.
  • Competitive compensation and benefits.

How to Apply

If you meet the qualifications and are excited about this opportunity, we encourage you to apply before the deadline.

Application Deadline: March 31, 2025

Application Link