$5,00,000 Per Year
$18,00,000 Per Year
Position: Senior Clinical Data Manager We seek a dedicated and solutions-focused Senior Clinical Data Manager to join our cross-functional, high-performing team. The successful candidate will be part of a collaborative, high-performance environment committed to excellence. Scope of Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. Participate in regulatory inspections, health authority meetings, and internal audits. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. 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. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Competencies and Qualifications: Strong interpersonal and stakeholder management skills with a client-service orientation. Proficiency in relevant software and digital tools specific to the functional area. Ability to work both independently and in a team-oriented, collaborative environment. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. 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.