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Safety Systems, Assistant Manager

6+ 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

 

Safety Systems Assistant Manager – Clinical Systems (Bangalore)

Location: Bangalore, India
Work Mode: Hybrid (Office or Remote)
Category: Clinical Systems & Pharmacovigilance
Experience Level: 6+ Years
Job Type: Full-Time


Job Summary

Fortrea is seeking a seasoned Safety Systems Assistant Manager to lead pharmacovigilance system operations, data migrations, and PV software support. This role involves working with safety platforms like Argus, ARISg, or Veeva, handling system configurations, training, UAT, and ticket management. Ideal for professionals with strong knowledge of drug safety databases, SQL, and clinical systems operations.


Key Responsibilities

  • Configure and maintain global safety systems for pharmacovigilance operations

  • Execute system migrations, change control processes, and technical documentation

  • Conduct routine and ad hoc data extraction (PSURs, DSURs, listings)

  • Manage vendor relationships and coordinate issue resolution

  • Support and train end users, collaborating with training teams on PV modules

  • Lead technical discussions and document user requirements

  • Perform user acceptance testing and maintain compliance with PV regulations

  • Monitor system mailboxes and address system failures

  • Participate in updating SOPs, guidelines, and working practices

  • Act as a Subject Matter Expert on safety database usage, MedDRA, and SMQ queries


Required Skills & Qualifications

  • Bachelor’s degree in Life Sciences, IT, or related field (or equivalent experience)

  • Minimum 6 years of experience with Argus, ARISg, or Veeva Vault Safety systems

  • Hands-on experience with validated document management systems

  • Proficiency in SQL and Microsoft Office tools

  • Strong background in system integration and technical troubleshooting

  • Excellent written and verbal communication skills

  • Strong attention to detail and ability to manage multiple priorities


Preferred Qualifications

  • Experience in pharmacovigilance, drug safety, or clinical data systems

  • Strong documentation and UAT execution skills

  • Knowledge of change management principles and SOP governance

  • Team leadership and mentoring capabilities


Perks & Benefits

  • Flexible hybrid work setup (office or remote)

  • Opportunity to work on global PV systems projects

  • Career development and internal training programs

  • Inclusive and innovative work environment

  • Work-life balance and competitive compensation


Company Description

Fortrea is a global Contract Research Organization (CRO) offering cutting-edge clinical development and pharmacovigilance technology solutions. With operations across 100+ countries and experience in over 20 therapeutic areas, Fortrea empowers pharmaceutical and biotech partners to bring breakthrough therapies to market faster.


Work Mode

Hybrid – Office-based or Remote (as per team and project needs)


Call to Action

Join Fortrea and play a vital role in transforming pharmacovigilance systems on a global scale. If you’re passionate about safety data and clinical tech, apply now to become a part of our expert team.