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Clinical Research Coordinator

Novotech

Bangalore, Hyderabad

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2 w

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Full time

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Healthcare

Minimum

$3,00,000 Per Year

Maximum

$7,00,000 Per Year

Position: Clinical Research Coordinator We are on the lookout for a well-rounded Clinical Research Coordinator to contribute to our operational and strategic priorities. The organisation is committed to nurturing talent and providing a platform for exceptional career growth. Core Responsibilities: Coordinate with CROs and licensing partners to fulfil pharmacovigilance obligations. Ensure audit-readiness of safety documentation in line with GxP and regulatory expectations. Ensure all cases are coded and processed per MedDRA and applicable global 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. Contribute to risk management plans, SOPs, and signal detection and evaluation processes. Maintain up-to-date knowledge of ICH E2A-E2F, GCP, and pharmacovigilance regulations. Conduct structured literature reviews and contribute to scientific summaries and labelling. Minimum Qualifications: Collaborative, proactive, and able to operate effectively with minimal supervision. Excellent attention to detail and commitment to producing accurate, high-quality deliverables. Expertise in applying quantitative and qualitative methods to support evidence-based decisions. Knowledge of applicable regulatory frameworks, industry standards, and compliance requirements. Superior writing and communication skills with experience preparing executive-level documents. Strong project management capabilities with experience in agile or structured methodologies. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. A competitive compensation structure along with performance incentives and growth opportunities awaits the right candidate.