Safety Science Specialist – Fortrea | Bangalore, India
Job ID: 255848
Location: Bangalore
Employment Type: Full-Time
Experience Required: Fresher candidates eligible
Application Deadline: 12 December 2025
Role Overview
Fortrea is seeking a Safety Science Specialist to support global pharmacovigilance and clinical safety operations. This role involves managing adverse event data from clinical trials and post-marketing sources, ensuring timely processing, and maintaining compliance with global regulatory requirements. The position is well-suited for freshers aspiring to build a strong foundation in drug safety, safety operations, and clinical research.
You will contribute to safety case processing, expedited reporting, regulatory submissions, quality review, and cross-functional collaboration within clinical and post-marketing safety programs.
Key Responsibilities
Adverse Event Case Processing
Receive, process, and track adverse event and serious adverse event reports from clinical trials and spontaneous sources.
Perform accurate data entry into safety databases and ensure completeness of records.
Assess cases for expedited reporting in accordance with global regulatory timelines.
Write clear, compliant patient narratives and code events using MedDRA.
Evaluate listedness against product labels for marketed products.
Identify missing clinical information and coordinate follow-up with relevant stakeholders.
Ensure cases receive timely medical review and quality assessment.
Expedited and Periodic Reporting
Prepare and submit expedited safety reports (SAEs/ESRs) to clients, regulatory agencies, ethics committees, investigators, partners, and third-party vendors within study-defined timelines.
Support preparation and submission of Periodic Safety Reports (PSRs).
Maintain adverse event tracking systems and safety documentation.
Coordinate database reconciliation with Data Management teams.
Safety Operations Support
Assist in maintaining study-specific documentation, central files, tracking logs, and safety metrics.
Support safety committee or DSMB data preparation requirements.
Participate in quality reviews, peer reviews, and contribute to trend identification and corrective action planning.
Assist in audit and inspection preparation and support ongoing compliance activities.
Ensure adherence to all pharmacovigilance SOPs, work instructions, guidelines, and regulatory directives.
Cross-Functional Collaboration
Build strong working relationships across pharmacovigilance, clinical operations, data management, regulatory teams, and project stakeholders.
Support client communication and project updates as required.
Contribute to organizational knowledge with consistent, high-quality work and team collaboration.
Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biological Sciences, Medical Sciences, Nursing, or a related discipline.
Freshers may apply; prior exposure or academic experience in pharmacovigilance, clinical research, or safety data management is beneficial.
Knowledge of AE/SAE processing, narrative writing, regulatory timelines, and safety databases is an added advantage.
Skills and Competencies
Strong attention to detail and accuracy.
Ability to work independently with minimal supervision.
Effective written and verbal communication skills.
Strong organizational and time-management skills.
Familiarity with MS Office applications.
Willingness to work collaboratively within global and cross-functional teams.
Ability to understand and follow regulatory and procedural requirements.
Job Location
Bangalore, India
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