Position: Clinical Data Manager We are seeking a highly qualified and motivated Clinical Data Manager to join our dynamic and growing team. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Core Responsibilities: Participate in regulatory inspections, health authority meetings, and internal audits. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Support collection and review of adverse event safety data from clinical and post-market sources. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Minimum Qualifications: Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Collaborative, proactive, and able to operate effectively with minimal supervision. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Strong project management capabilities with experience in agile or structured methodologies. 4+ years of experience with a demonstrated track record of growth and professional impact. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.