$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager We seek a dedicated and solutions-focused Clinical Data Manager to join our cross-functional, high-performing team. The selected professional will thrive in a data-driven, efficiency-focused, and collaborative work environment. Core Responsibilities: Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. 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. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Minimum Qualifications: Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Superior writing and communication skills with experience preparing executive-level documents. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. 4+ years of experience with a demonstrated track record of growth and professional impact. Collaborative, proactive, and able to operate effectively with minimal supervision. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. We are committed to fostering an inclusive workplace and welcome applications from candidates of all backgrounds.