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Clinical Data Manager

GeorgeClinical

Bangalore, Mumbai

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2 w

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Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$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 candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Responsibilities Include: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. 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. Ensure all cases are coded and processed per MedDRA and applicable global standards. Participate in regulatory inspections, health authority meetings, and internal audits. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Skills and Qualifications: Demonstrated teamwork skills and the ability to build trust and rapport across functions. 26 years of relevant industry experience with evidence of increasing responsibility. Bachelor's or master's degree in a related discipline with strong academic and professional credentials. Hands-on experience with tools, software, and platforms standard to the profession. A structured, results-driven approach with the ability to meet defined milestones consistently. Strong communication, presentation, and interpersonal skills across all organisational levels. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. This position represents a unique platform for a high-calibre professional to make a lasting contribution.