Pharmacovigilance Expert - Remote

A Pharmacovigilance Expert is needed to work remotely on a contract basis. The company focuses on developing advanced healthcare AI systems. The expert will use their drug safety knowledge to enhance these systems by examining and improving pharmacovigilance documents, safety reports, and regulatory information. The main tasks involve creating and reviewing evaluation tasks based on various safety reports and data. The expert will assess safety findings, signal evaluations, and benefit-risk conclusions for accuracy and regulatory compliance. They will also review reports to ensure they meet specific guidelines and analyze safety data to resolve any inconsistencies. Additionally, the expert will provide detailed feedback to support AI-driven pharmacovigilance tools and ensure the quality of regulatory safety documentation. To qualify, candidates must have a strong background in pharmacovigilance, including experience with drug safety report authoring, DSUR/PSUR/PBRER review, and compliance with ICH E2F, ICH E2C(R2), and GVP guidelines. They should be skilled in aggregate safety data analysis, signal management, benefit-risk assessment, MedDRA coding, and seriousness and causality assessment. Attention to detail and structured written communication are also crucial. Nice-to-have skills include experience in clinical development safety, post-marketing surveillance, QPPV/deputy QPPV roles, safety committees, or AI-assisted safety review tools. The role offers the opportunity to work remotely, providing flexibility and the chance to contribute to cutting-edge healthcare AI projects. What the role asks for: - Experience in pharmacovigilance or drug safety. - Knowledge of ICH E2F, ICH E2C(R2), and GVP guidelines. - Ability to author or review DSURs and/or PSURs/PBRERs. - Skills in aggregate safety data analysis. - Proficiency in signal management. - Experience with benefit-risk assessment. - MedDRA coding skills. - Experience in seriousness and causality assessment. - Experience in data reconciliation. - Experience in regulatory documentation. - Structured written communication skills. - Attention to detail. - Nice-to-have: 5+ years of experience in pharmacovigilance or drug safety. - Nice-to-have: Advanced degree in life sciences, pharmacy, nursing, medicine, or related fields (PharmD, MD, MSc, or equivalent).