Pharmacovigilance Writer

Job Summary

Responsible for writing safety documents and patient CSR narratives, the full-time Pharmacovigilance Writer will work remotely during US EST hours, ensuring compliance with regulatory guidelines and managing client feedback throughout the document lifecycle.

Key responsibilities

• Write safety documents and high-quality patient CSR narratives for regulatory submissions
• Manage revisions and address client comments independently during the document lifecycle
• Ensure compliance with ICH and regulatory guidelines while providing excellent customer service

Required qualifications

• Minimum of 2 years of experience in a regulated scientific, clinical, or pharmaceutical environment
• University graduate in a scientific, medical, or clinical discipline; Master's or PhD preferred
• Experience leading complex CSR narrative projects, with a preference for an Oncology background
• Familiarity with ICH guidelines relevant to medical writing for clinical studies
• Proficient in Microsoft Word and Adobe Acrobat, with experience in Electronic Document Management systems