$5,00,000 Per Year
$18,00,000 Per Year
Position: Clinical Data Manager A compelling career opportunity exists for a skilled Clinical Data Manager to drive meaningful impact. The organisation fosters a culture of continuous learning, development, and shared organisational accountability. Key Responsibilities: Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Participate in regulatory inspections, health authority meetings, and internal audits. Support collection and review of adverse event safety data from clinical and post-market sources. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Qualifications and Requirements: Minimum 35 years of progressive professional experience in a comparable role. Proven ability to manage competing priorities in a deadline-driven, dynamic environment. Excellent verbal and written communication skills; fluency in English is essential. Demonstrated proficiency with industry-standard tools, platforms, and methodologies. Strong analytical and problem-solving skills with the ability to navigate complex challenges. Experience collaborating within cross-functional teams and matrix organisational structures. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Successful candidates will receive access to ongoing professional development and industry-leading resources.