Position: Principal Clinical Data Engineer We are expanding our team and seek a driven Principal Clinical Data Engineer who brings expertise, initiative, and professionalism. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Core Responsibilities: Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Support collection and review of adverse event safety data from clinical and post-market sources. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure all cases are coded and processed per MedDRA and applicable global standards. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. 4+ years of experience with a demonstrated track record of growth and professional impact. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Superior writing and communication skills with experience preparing executive-level documents. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.