Pharmacovigilance Writer

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