Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Support collection and review of adverse event safety data from clinical and post-market sources. Conduct structured literature reviews and contribute to scientific summaries and labelling. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. 4+ years of experience with a demonstrated track record of growth and professional impact. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Superior writing and communication skills with experience preparing executive-level documents. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We offer a competitive remuneration package commensurate with experience and market standards. Qualified candidates are encouraged to apply.