$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager We are expanding our team and seek a driven Clinical Data Manager who brings expertise, initiative, and professionalism. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Key Responsibilities: Ensure all cases are coded and processed per MedDRA and applicable global standards. Support collection and review of adverse event safety data from clinical and post-market sources. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Conduct structured literature reviews and contribute to scientific summaries and labelling. 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. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Qualifications and Requirements: Experience collaborating within cross-functional teams and matrix organisational structures. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Minimum 35 years of progressive professional experience in a comparable role. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. Excellent verbal and written communication skills; fluency in English is essential. 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.