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Clinical Data Manager

EliLilly

Mumbai, Bangalore

·

2 w

·

Full time

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Healthcare

Minimum

$5,00,000 Per Year

Maximum

$18,00,000 Per Year

Position: Clinical Data Manager We are seeking a highly qualified and motivated Clinical Data Manager to join our dynamic and growing team. The candidate will join a globally connected team that prizes diverse perspectives and operational excellence. Scope of Responsibilities: Prepare high-quality clinical and regulatory documents aligned to CTD submission standards. Review and analyse PSURs, PBRERs, DSURs, and other aggregate safety reports. Liaise with clinical, medical affairs, and regulatory teams for accurate safety data management. Conduct structured literature reviews and contribute to scientific summaries and labelling. Assist in preparing and submitting regulatory safety reports in compliance with ICH guidelines. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Participate in regulatory inspections, health authority meetings, and internal audits. Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Competencies and Qualifications: Proficiency in relevant software and digital tools specific to the functional area. At least 24 years of hands-on experience in a comparable professional setting. Commitment to ongoing professional learning and industry knowledge enhancement. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Exceptional organisational skills with the ability to handle multiple concurrent responsibilities. Strong interpersonal and stakeholder management skills with a client-service orientation. 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.