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Senior Safety Systems Specialist

3+ years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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

 

Senior Safety Systems Specialist – Pharmacovigilance (Bangalore)

Location: Bangalore, India
Work Mode: Hybrid (Office or Remote)
Category: Clinical | Safety Systems
Experience Required: Minimum 3 years with drug safety systems


Job Summary

Fortrea is hiring a Senior Safety Systems Specialist to support the implementation, configuration, and migration of global drug safety systems including Argus, ARISg, and Veeva. This hybrid role in Bangalore offers an opportunity to work with validated systems for pharmacovigilance reporting, compliance, and regulatory documentation in a clinical research environment. Ideal for IT or life science professionals experienced in safety databases and clinical systems.


Key Responsibilities

  • Manage configurations and upgrades of drug safety systems

  • Perform safety database migrations and document changes

  • Develop and maintain standard and ad hoc PV reports

  • Collaborate with stakeholders to capture and deliver system requirements

  • Provide end-user support and training for pharmacovigilance tools

  • Perform user acceptance testing (UAT) and maintain compliance documentation

  • Respond to system-related queries and resolve technical issues

  • Contribute to process improvements and SOP updates

  • Strategize use of SMQs and front-end safety system reporting

  • Support PSURs, DSURs, and ad hoc safety data extractions


Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, IT, or related field

  • Minimum 3 years of experience with drug safety systems (e.g., Argus, ARISg, Veeva)

  • Experience in system integration and validated document management

  • Working knowledge of Microsoft Office Suite

  • Familiarity with pharmacovigilance workflows and compliance standards

  • Good understanding of SQL preferred

  • Strong communication and documentation skills

  • Attention to detail with excellent analytical capabilities


Perks & Benefits

  • Hybrid work flexibility

  • Global exposure to PV system implementation projects

  • Career growth in drug safety and clinical systems

  • Collaborative, cross-functional work culture

  • Training support and learning resources


Company Description

Fortrea is a leading global Contract Research Organization (CRO) delivering advanced clinical development and technology solutions to pharmaceutical, biotech, and medical device companies. With operations in nearly 100 countries and experience across 20+ therapeutic areas, Fortrea accelerates the development of innovative therapies through clinical trials and compliance-driven safety systems.


Work Mode

Hybrid – Office-based in Bangalore with flexibility for remote work.


Call to Action

Are you a skilled pharmacovigilance system professional ready to elevate your clinical career? Apply now to join Fortrea as a Senior Safety Systems Specialist and play a critical role in improving global drug safety operations.