Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Safety Systems Specialist

Fortrea
Fortrea
2 years
Not Disclosed
Bangalore, India
10 April 22, 2026
Job Description
Job Type: Hybrid Education: B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology) 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

Job Title:

PV Systems / Safety Tools Specialist


Job Overview:

The PV Systems Specialist supports the implementation, configuration, maintenance, and migration of safety trackers, applications, and tools. The role involves working closely with business and technical teams to ensure efficient system performance, high-quality data handling, and compliance with pharmacovigilance (PV) requirements.


Experience Required:

  • Minimum 2+ years of experience with drug safety trackers/applications/tools
  • Experience in operations support for safety systems
  • Experience with validated document management systems

Key Skills & Requirements:

Technical Skills:

  • Knowledge of safety systems such as:
    • SAE (Serious Adverse Event) trackers
    • Intake/ESR trackers
    • SharePoint or in-house developed tools
  • Basic understanding of system integration
  • Proficiency in Microsoft Office tools
  • Preferred: Knowledge of SQL programming

Core Responsibilities:

System Configuration & Maintenance:

  • Configure safety trackers/applications based on project requirements
  • Maintain and document system configurations and updates
  • Support system implementation and migration activities

Data Management & Reporting:

  • Develop and generate standard and ad hoc reports
  • Perform data extraction for:
    • PSURs
    • DSURs
    • Periodic listings
  • Utilize Standard MedDRA Queries (SMQ) for reporting

Business Analysis & Collaboration:

  • Gather and document user requirements from stakeholders
  • Perform technical impact analysis and evaluate business value
  • Work closely with technical teams to ensure timely delivery

User Support & Training:

  • Provide support to end users and clients
  • Collaborate in developing training modules
  • Train team members on technical and functional aspects

Issue & Change Management:

  • Manage tickets, resolve issues, and escalate when required
  • Monitor system performance and handle failures
  • Support change management processes

Migration & Testing:

  • Participate in data migration activities and documentation
  • Perform User Acceptance Testing (UAT) and maintain records

Quality, Compliance & Process Improvement:

  • Ensure adherence to SOPs and PV regulations
  • Update SOPs, guidelines, and working practices
  • Identify opportunities to improve compliance, quality, and efficiency

Leadership & Coordination:

  • Lead critical team projects and manage workload
  • Handle vendor management and stakeholder coordination
  • Respond to mailbox queries and manage communications

Qualifications (Minimum Required):

  • Bachelor’s degree in Life Sciences or IT/Computing
  • Equivalent experience may be considered

Skills & Competencies:

  • Strong attention to detail and accuracy
  • Good written and verbal communication skills
  • Ability to prioritize and manage multiple tasks
  • Strong analytical and logical thinking
  • Good teamwork and collaboration skills
  • Basic numerical data handling and proofreading ability

Preferred Qualifications:

  • Clinical background with experience in clinical systems
  • Experience with ticketing/support applications
  • Knowledge of SQL

Work Environment:

  • Office-based work setup
  • Regular use of computer and standard office equipment