Safety & PV Specialist I

📋 Description

• Enter, track, and maintain pharmacovigilance information in quality and safety tracking systems
• Triage and review ICSRs for completeness, accuracy, and regulatory reportability, and enter
• Code adverse events, medical history, concomitant medications, tests, products, and other safety
• Prepare complete and accurate case narratives, identify missing information, and follow up on
• Support the timely generation and reporting of expedited safety reports in accordance with
• Perform literature screening and review activities, including drug coding, MedDRA coding, and

🎯 Requirements

• Bachelor’s degree in a life science discipline, or qualification as a registered nurse, pharmacist
• Experience or knowledge of safety database systems and medical terminology.
• Good understanding of clinical trial processes across Phases II–IV and/or post-marketing safety
• Knowledge of ICH GCP, GVP, and regulations applicable to safety and pharmacovigilance activities.
• Proficiency with Microsoft Office tools, including Word, Excel, and PowerPoint, as well as
• Strong attention to detail and a high degree of accuracy when handling safety and regulatory

🎁 Benefits

• Remote work opportunity in Brazil.
• Full-time position within a global life sciences and healthcare environment.
• Career development and progression opportunities.
• Supportive and engaged line management.
• Technical and therapeutic-area training.
• Peer recognition and total rewards programs.