$5,00,000 Per Year
$18,00,000 Per Year
Position: Senior Clinical Data Manager We are on the lookout for a well-rounded Senior Clinical Data Manager to contribute to our operational and strategic priorities. The incumbent will operate in a structured yet agile environment that prioritises quality and professional growth. Duties and Accountabilities: Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Participate in regulatory inspections, health authority meetings, and internal audits. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Key Skills and Qualifications: Leadership experience with a track record of guiding teams, projects, or cross-functional initiatives. 5+ years of experience with demonstrated progression in scope, complexity, and responsibility. Effective presentation skills with the ability to communicate complex ideas with clarity. Advanced competency in analytical tools, reporting platforms, and role-specific technology. Sound understanding of organisational dynamics and stakeholder management in complex environments. Recognised qualification in the relevant professional field at the undergraduate or graduate level. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This is an outstanding opportunity for a motivated professional to advance their career within a reputable organisation.