Drug Safety Systems Specialist Vacancies at Fortrea
- Company Overview
- Job Role & Responsibilities
- Core Safety Systems Responsibilities
- Data Management, Reporting & Integration
- Stakeholder & Client Support
- Quality, Compliance & Continuous Improvement
- Eligibility / Qualifications
- Location
- Application Process
- Frequently Asked Questions
- Is this role suitable for freshers?
- Is this a technical or clinical role?
- Does the role support global regulatory reporting?
- Is this a hybrid position?
- What career growth is available?
Life science or IT graduates required for Safety Systems Specialist vacancies at Fortrea, Bangalore. Hybrid role.
Pharmacovigilance systems and safety technology play a critical role in ensuring patient safety, regulatory compliance, and efficient drug safety operations. Fortrea is hiring a Safety Systems Specialist for its Bangalore location in a hybrid work model. This role is ideal for professionals with experience in drug safety systems, PV trackers, and validated applications who want to build long-term careers at the intersection of pharmacovigilance, technology, and regulatory compliance.
Company Overview
Fortrea is a global contract research organization specializing in clinical development, pharmacovigilance, and regulatory services. The organization supports pharmaceutical, biotechnology, and medical device companies across the full drug development lifecycle, with a strong emphasis on patient safety and data integrity.
With a global delivery model and deep expertise in safety operations, Fortrea manages complex pharmacovigilance systems, safety databases, and regulatory reporting for clients operating in highly regulated markets such as the United States, Europe, and other international regions. The company is recognized for its scientific rigor, compliance-driven culture, and investment in advanced safety technologies.
Job Role & Responsibilities
The Safety Systems Specialist role focuses on implementation, support, configuration, and optimization of pharmacovigilance trackers, applications, and safety tools. This position combines technical expertise with business understanding to support global drug safety operations.
Core Safety Systems Responsibilities
• Provide operational support for safety trackers, applications, and PV tools • Configure and maintain safety systems based on project-specific and evolving requirements • Support implementation, migration, and enhancement activities for safety applications • Act as subject matter expert for pharmacovigilance systems and front-end reporting tools • Develop and maintain documentation related to system configuration and changes
Data Management, Reporting & Integration
• Develop standard and ad hoc reports from safety trackers and applications • Conduct routine and ad hoc data extractions for PSURs, DSURs, and six-monthly listings • Support safety system integration and data migration activities • Perform User Acceptance Testing and complete associated documentation • Utilize Standard MedDRA Queries and advanced reporting conditions for signal detection
Stakeholder & Client Support
• Collaborate with business stakeholders to gather, document, and deliver user requirements • Support and educate end users, sponsors, and internal teams on safety systems usage • Coordinate with training teams to develop system-specific training modules • Manage ticketing systems, issue resolution, and escalation of system-related problems • Respond to mailbox queries and monitor trackers for failures or performance issues
Quality, Compliance & Continuous Improvement
• Ensure all activities comply with global pharmacovigilance regulations and SOPs • Update departmental SOPs, working practices, and guidelines as required • Identify opportunities to improve compliance, quality, and operational efficiency • Lead or support critical team projects and manage workload distribution • Train team members on functional and technical aspects of safety systems
Eligibility / Qualifications
This role is suitable for professionals with hands-on experience in drug safety systems and validated applications.
Minimum qualifications:
• Degree in Life Sciences or IT / Computing or equivalent experience • At least 2 years of experience with drug safety trackers, applications, or systems • Experience supporting safety tools such as intake, SAE, or ESR trackers • Working knowledge of validated document management systems • Proficiency in Microsoft Office applications • Strong analytical, organizational, and communication skills
Relevant educational background includes: BSc Life Sciences, MSc Life Sciences, Pharmacy, Biotechnology, Clinical Research, Information Technology, Computer Science
Preferred qualifications:
• Clinical background working with clinical or safety systems • Knowledge of SQL programming • Experience with ticketing or IT support applications • Exposure to safety system integration and migration projects
Location
Job Location: Bangalore
Application Process
Eligible candidates can apply directly through the official Fortrea careers portal using the link below:
Shortlisted candidates will be contacted by the recruitment team for further evaluation and next steps.
Frequently Asked Questions
Is this role suitable for freshers?
No. This role requires prior experience with drug safety systems or PV applications.
Is this a technical or clinical role?
This is a hybrid role combining pharmacovigilance knowledge with technical system expertise.
Does the role support global regulatory reporting?
Yes. The role supports PSURs, DSURs, and other global safety reporting activities.
Is this a hybrid position?
Yes. The role follows a hybrid work model based in Bangalore.
What career growth is available?
Professionals can grow into senior PV systems, safety technology, or consulting roles.
| Category | Details |
|---|---|
| Company | Fortrea |
| Vacancies | Safety Systems Specialist |
| Required Education | Life Sciences, Pharmacy, IT, Computer Science |
| Experience | 2+ Years |
To apply for this job please visit Drug%20Safety%20Systems%20Specialist%20Vacancies%20at%20Fortrea.
