$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager An exceptional opportunity has arisen for a talented Clinical Data Manager to contribute to our mission. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Key Responsibilities: Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Participate in regulatory inspections, health authority meetings, and internal audits. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Support collection and review of adverse event safety data from clinical and post-market sources. Qualifications and Requirements: Proven ability to manage competing priorities in a deadline-driven, dynamic environment. A bachelor's degree or higher in a relevant field; postgraduate qualifications are an added advantage. High degree of professionalism, integrity, and alignment with organisational values. Excellent verbal and written communication skills; fluency in English is essential. Minimum 35 years of progressive professional experience in a comparable role. Experience collaborating within cross-functional teams and matrix organisational structures. 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.