Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Scope of Responsibilities: Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. 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. 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. Participate in regulatory inspections, health authority meetings, and internal audits. Ensure all cases are coded and processed per MedDRA and applicable global standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Competencies and Qualifications: Detail-oriented mindset with the ability to synthesise and present complex information clearly. At least 24 years of hands-on experience in a comparable professional setting. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.