Fortrea, a leading global contract research organization (CRO), is seeking a skilled Safety Science Specialist to join its team in Pune, India. This full-time role offers an excellent opportunity for professionals in pharmacy or life sciences to advance their careers in pharmacovigilance and clinical safety operations.
With a deadline to apply by July 15, 2025, now is the time to explore this exciting opportunity with Fortrea.
About the Safety Science Specialist Role at Fortrea
The Safety Science Specialist will play a pivotal role in managing adverse event (AE) and serious adverse event (SAE) reports, ensuring compliance with regulatory requirements and maintaining high standards of data accuracy. This position is ideal for individuals passionate about patient safety and clinical excellence.
Key Responsibilities
Processing Adverse Events: Handle AE and SAE reports from various sources, ensuring timely and accurate processing.
Data Management: Enter and maintain safety data in databases, ensuring quality and precision.
Narrative Writing and Coding: Write patient narratives and code adverse events using the Medical Dictionary for Regulatory Activities (MedDRA).
Regulatory Compliance: Submit expedited reports to regulatory authorities, clients, and other stakeholders as required.
Database Reconciliation: Support safety database reconciliation and generate safety metrics for reporting.
Documentation and Tracking: Maintain accurate project documentation and tracking systems.
Audit and Inspection Support: Prepare data for audits, inspections, and safety review committees.
Compliance and Quality: Adhere to standard operating procedures (SOPs) and regulatory guidelines, supporting corrective and preventive action (CAPA) development when needed.
Candidate Profile
Fortrea is looking for candidates with the following qualifications and skills:
Education: PharmD, MPharm, BPharm, or a degree in Nursing, Medical Sciences, or Life Sciences.
Experience: At least 3 years of relevant experience in pharmacovigilance or clinical safety operations.
Skills:
Hands-on experience with AE/SAE case processing and regulatory submissions.
Proficiency in safety databases and MS Office applications.
Strong attention to detail and documentation skills.
Excellent communication and presentation abilities.
Ability to work independently and collaboratively in a team.
Training or mentoring experience is a plus.
Work Environment
The role offers flexibility with an office-based or remote work setup, depending on business needs. Fortrea fosters a collaborative and innovative workplace, empowering employees to contribute to meaningful clinical research while advancing their careers.
Why Join Fortrea?
Fortrea is committed to quality, innovation, and integrity, offering employees the chance to make a global impact in healthcare. As a Safety Science Specialist, you’ll work with a team dedicated to patient safety and clinical excellence, with opportunities for professional growth and development.
How to Apply
Ready to take the next step in your pharmacovigilance career? Apply for the Safety Science Specialist position at Fortrea by July 15, 2025. Visit the Fortrea careers page and reference Job Requisition ID: 253794 to submit your application. Don’t miss this chance to join a global leader in clinical research.
Authoritative Sources
[width: Fortrea Careers Page
ICH Guidelines for Pharmacovigilance
MedDRA Official Website