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🔹 Fortrea

| Published on: 18th July 2025
📌 Position: Safety Science Analyst
👥 Experience: Fresher
🎓 Qualification: B.Pharm / M.Pharm / Pharm.D

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About Fortrea:

Fortrea is a global Contract Research Organization (CRO) dedicated to advancing patient safety and clinical development. Known for its commitment to quality, Fortrea collaborates with pharmaceutical, biotech, and medical device companies to bring safe and effective therapies to market. With strong regulatory practices and an innovation-driven approach, Fortrea continues to be a trusted partner in global drug development.

Position: Safety Science Analyst

As a Safety Science Analyst, your key responsibilities will include:

1. Case Processing & Adverse Event Management

  • Intake and triage of safety reports from clinical trials and marketed products

  • Enter adverse events into safety databases and code events using MedDRA

  • Write patient narratives and assist with listedness assessment

2. Regulatory Compliance & Reporting

  • Submit SAE reports to clients, regulators, and investigators

  • Assist in periodic safety report submissions (e.g., PSURs, DSURs)

  • Ensure compliance with ICH-GCP, FDA, EMA, and other global standards

3. Quality & Documentation

  • Adhere to SOPs, Work Instructions, and QMS guidelines

  • Maintain country-wise adverse event documentation

  • Support database reconciliation and case documentation archival

4. Collaboration & Safety Compliance

  • Collaborate with Pharmacovigilance and Clinical Safety teams

  • Comply with Health & Safety regulations, including COSHH and EC directives

Hiring Process:

Mode: Online Application via Fortrea Job Portal

Eligibility Criteria:

  • Qualification: B.Pharm / M.Pharm / Pharm.D

  • Experience: Fresher

  • Knowledge of MedDRA coding, ICH-GCP, and global safety regulations preferred

  • Good documentation and communication skills

How to Apply:

  • Click the job link provided Below

  • Submit your CV and any additional documents on the Fortrea careers portal

📌 Note: This is an online application process.