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Clinical Data Manager

SiemensAG

Hyderabad, Mumbai

·

3 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. Core Responsibilities: Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. 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. Conduct structured literature reviews and contribute to scientific summaries and labelling. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Support collection and review of adverse event safety data from clinical and post-market sources. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Participate in regulatory inspections, health authority meetings, and internal audits. Minimum Qualifications: Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Superior writing and communication skills with experience preparing executive-level documents. Relevant undergraduate or postgraduate degree aligned with the role's core responsibilities. Strong project management capabilities with experience in agile or structured methodologies. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. 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.