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Senior Safety Systems Specialist

Fortrea
Fortrea
3+ years
Not Disclosed
10 Sept. 25, 2025
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Location: Bangalore
Category: Clinical
Job ID: 254873


Job Overview

The Senior Safety Systems Specialist will assist with the implementation, support, configuration, and migration of safety systems. The role involves providing high-quality service to clients, either as a support function to project groups or as a standalone business. The candidate is expected to comply with legal requirements including the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3, as outlined in the company’s Health and Safety Manual.


Qualifications (Minimum Required)

  • Degree in Life Sciences or IT/Computing.

  • Relevant and equivalent experience may be considered in lieu of a degree.

  • Minimum 3 years of experience with drug safety systems such as Argus, ARISg, Veeva, or equivalents.

  • Proficient in Microsoft Office tools.

  • Knowledge of system integration.


Summary of Responsibilities

  • Act as a PV systems team member, leveraging business and technical knowledge.

  • Conduct project-specific configurations in safety systems.

  • Maintain and document system configurations, including updates.

  • Develop and document standard and ad hoc reports from safety systems.

  • Support and educate end users and sponsors as applicable.

  • Collaborate with the training team to develop safety system-specific modules.

  • Engage with business stakeholders to understand and document requirements; ensure timely delivery in collaboration with technical partners.

  • Provide guidance on front-end reporting, including advanced conditions and Standard MedDRA Queries (SMQ).

  • Conduct routine and ad hoc data extraction (PSURs, DSURs, 6-monthly listings).

  • Participate in data migration activities and related documentation.

  • Support change management and training as needed.

  • Manage tickets, resolve issues, and escalate system issues when necessary.

  • Update departmental SOPs, working practices, and guidelines.

  • Serve as a subject matter expert, identifying opportunities to improve compliance, quality, and efficiency.

  • Respond to mailbox queries.

  • Ensure work assignments meet quality standards, adhere to SOPs, and comply with PV regulations.

  • Perform User Acceptance Testing (UAT) and document results.

  • Carry out any other duties as assigned by management.


Experience (Minimum Required)

  • Experience in systems operations support.

  • Experience with validated document management.

  • Strong keyboard and MS Office skills.

  • Ability to operate standard office equipment.


Preferred Qualifications

  • Clinical background with experience in clinical systems.

  • Knowledge of SQL programming.

  • Strong team player, able to provide peer support.

  • Ability to prioritize tasks and manage multiple assignments.

  • Attention to detail with strong logical, spelling, and proofreading skills.

  • Excellent written and verbal communication.


Physical Demands / Work Environment

  • Office environment or remote work