Drug Safety Systems Specialist Vacancies at Fortrea

Fortrea Hiring Safety Systems Specialist (Argus Safety / PV Systems)  | Bengaluru Hybrid Role

Fortrea is hiring Safety Systems Specialist professionals for its Pharmacovigilance and Safety Systems division in Bengaluru, India. This is a full-time hybrid opportunity for candidates with at least 2 years of experience in drug safety systems, pharmacovigilance tools, and clinical safety databases. The role focuses on safety system configuration, ICSR tracking tools, and regulatory reporting support, making it a strong career move for professionals in PV systems, Argus safety, and clinical data management.

Company Overview

Fortrea is a leading global contract research organization (CRO) providing clinical development, patient access, and safety solutions to pharmaceutical, biotechnology, and medical device companies. With a strong focus on innovation and technology-driven clinical research, Fortrea supports global drug development programs and pharmacovigilance operations.

The company is recognized for its expertise in safety systems, regulatory compliance, and clinical data management, offering professionals exposure to global projects and advanced pharmacovigilance platforms.

Job Role & Responsibilities

As a Safety Systems Specialist, you will act as a subject matter expert in pharmacovigilance systems, supporting safety databases, trackers, and reporting tools used in global drug safety operations.

Core Responsibilities

• Configure, maintain, and support safety trackers and pharmacovigilance applications
• Manage safety systems such as SAE trackers, intake tools, and reporting platforms
• Perform data extraction for regulatory reports including PSURs, DSURs, and safety listings
• Conduct User Acceptance Testing (UAT) and ensure system validation compliance

System Management & Technical Support

• Maintain documentation for system configurations and updates
• Support system migrations, integrations, and upgrades
• Handle ticket management, issue resolution, and escalation processes
• Respond to system queries and ensure timely resolution of technical issues

Data & Reporting Activities

• Generate standard and ad-hoc reports from safety databases
• Ensure accurate data capture and compliance with pharmacovigilance guidelines
• Use MedDRA coding queries and advanced reporting tools for safety analysis

Collaboration & Training

• Work with cross-functional teams including IT, clinical, and regulatory departments
• Train end users on safety systems and tools
• Collaborate with stakeholders to gather requirements and implement system enhancements

Compliance & Quality

• Ensure adherence to SOPs, regulatory requirements, and pharmacovigilance standards
• Support audits, inspections, and documentation processes
• Continuously improve system efficiency, compliance, and quality standards

Eligibility / Qualifications

Educational Qualification

Candidates must have a degree in Life Sciences or IT-related disciplines.

Required courses include:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Computer Science, Information Technology, Biomedical Informatics, Clinical Research

Experience

• Minimum 2 years of experience in pharmacovigilance systems or safety database support
• Experience with safety tools such as Argus, SharePoint, or in-house PV systems

Skills Required

• Strong knowledge of drug safety systems and ICSR processing tools
• Experience with safety databases, trackers, and reporting systems
• Good understanding of pharmacovigilance regulations and compliance
• Strong analytical, troubleshooting, and problem-solving skills
• Proficiency in MS Office and data handling tools

Preferred Skills

• Knowledge of SQL and database querying
• Experience in clinical systems and ticket management tools
• Exposure to system integration and data migration processes

Location & Salary

• Job Location: Bengaluru, India
• Work Mode: Hybrid
• Employment Type: Full-time
• Salary: Competitive salary package based on experience in pharmacovigilance systems and clinical research technology

Application Process

Interested candidates can apply through the official Fortrea careers portal:

Apply Here: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Bangalore/Safety-Systems-Specialist–Argus-Safety-Consultant-_26130

Why This Role Matters in Healthcare

Safety Systems Specialists play a key role in ensuring accurate drug safety data management and regulatory compliance. By supporting pharmacovigilance systems and reporting tools, this role contributes directly to patient safety, regulatory transparency, and efficient clinical trial operations.

Frequently Asked Questions (FAQs)

1. What experience is required for this role?

Candidates need at least 2 years of experience in pharmacovigilance systems or safety database roles.

2. What qualifications are required?

A degree in Life Sciences or IT-related fields is required.

3. What tools should I know?

Knowledge of Argus Safety, safety trackers, SharePoint, and reporting tools is beneficial.

4. Is this a good pharma career option?

Yes. PV systems and drug safety technology roles are high-demand and offer strong career growth.

5. What skills are important?

Technical expertise in safety systems, problem-solving, data analysis, and regulatory compliance.

Summary Table

Category	Details
Company	Fortrea
Vacancies	Safety Systems Specialist
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, BSc, MSc (Life Sciences, Biotechnology, Microbiology, Biochemistry), Computer Science, Information Technology, Biomedical Informatics, Clinical Research
Experience	2+ Years Pharmacovigilance Systems Experience

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