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.
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