Position: Clinical Data Manager We are looking for a strategic and detail-oriented Clinical Data Manager to deliver excellence across key functions. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Responsibilities Include: Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. 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. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Ensure all cases are coded and processed per MedDRA and applicable global standards. Conduct structured literature reviews and contribute to scientific summaries and labelling. Skills and Qualifications: Hands-on experience with tools, software, and platforms standard to the profession. Strong communication, presentation, and interpersonal skills across all organisational levels. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. Willingness to travel, adapt, and take on additional responsibilities as the business demands. 26 years of relevant industry experience with evidence of increasing responsibility. A structured, results-driven approach with the ability to meet defined milestones consistently. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.