Application Deadline: April 26, 2025 (Only 9 hours left to apply!)
Job Requisition ID: 251881 / 251879
About Fortrea
Fortrea is a leading global contract research organization (CRO) committed to delivering high-quality clinical trial solutions to biopharmaceutical and medical device companies. With a strong focus on innovation, compliance, and patient safety, Fortrea provides comprehensive clinical development and commercialization services to accelerate drug development worldwide.
Join Fortrea’s dynamic team in Pune and contribute to advancing healthcare by ensuring the safety and efficacy of pharmaceutical products.
Job Description: Safety Science Analyst
Job Overview
As a Safety Science Analyst, you will assist in Clinical Safety and Pharmacovigilance (PSS) operations, managing adverse event (AE) reports from clinical trials and post-marketing surveillance. Your role ensures compliance with global regulatory requirements, timely submissions, and high-quality safety data management.
Key Responsibilities
- Perform case intake and triage of safety reports from clinical trials and spontaneous sources.
- Process adverse events, including:
- Data entry into safety databases.
- Writing patient narratives and coding AEs using MedDRA.
- Assessing listedness against product labels (for marketed products).
- Generate queries to resolve missing/discrepant data in consultation with medical teams.
- Submit expedited SAE reports to clients, regulatory authorities, and investigators within required timelines.
- Assist in periodic safety reports (PSURs, DSURs) submissions to global health authorities.
- Support database reconciliation and documentation maintenance.
- Ensure compliance with SOPs, Work Instructions (WIs), and regulatory guidelines (e.g., FDA, EMA, ICH-GCP).
- Maintain safety reporting documentation for global regulatory compliance.
- Collaborate with cross-functional teams to enhance pharmacovigilance operations.
Qualifications & Skills
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, or related field.
- Freshers or 1-2 years of experience in pharmacovigilance/drug safety.
- Knowledge of MedDRA coding, ICH-GCP, and global safety regulations (preferred).
- Strong attention to detail, analytical skills, and ability to work under deadlines.
- Proficiency in safety databases (Argus, ARISg, Veeva) & MS Office.
Why Join Fortrea?
✅ Global Exposure: Work with international clients and regulatory agencies.
✅ Career Growth: Opportunities in pharmacovigilance, clinical research, and regulatory affairs.
✅ Learning & Development: Training on safety databases and compliance standards.
✅ Work-Life Balance: Supportive work environment with flexible policies.
