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Clinical Data Manager

EliLilly

Mumbai, Bangalore

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4 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 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. Responsibilities Include: Conduct structured literature reviews and contribute to scientific summaries and labelling. Support collection and review of adverse event safety data from clinical and post-market sources. Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Participate in regulatory inspections, health authority meetings, and internal audits. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. 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. Skills and Qualifications: Willingness to travel, adapt, and take on additional responsibilities as the business demands. A structured, results-driven approach with the ability to meet defined milestones consistently. Familiarity with regulatory, compliance, or quality frameworks applicable to the industry. 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. Demonstrated teamwork skills and the ability to build trust and rapport across functions. 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.