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Novartis Healthcare Pvt Ltd

Novartis (NYSE: NVS) is a world leader in the research and development of products to protect and improve health and well-being. The company has core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health. Headquartered in Basel, Switzerland, Novartis employs nearly 115 000 people in over 140 countries worldwide to help save lives and improve the quality of life. The Group is present in India through Novartis India Limited, listed on the Mumbai Stoc... Read More

Address      Sandoz House Shivsagar Estate Dr Annie Besant Road Worli, Mumbai India
Website      www.novartis.in/
Holding      No Holding Details

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Clinical Coding Specialist

Provide timely and professional ongoing management of clinical trial coding data, Phases I to IV, by preparing coding module for validation plans. Manually code medical and therapy terms not encoded automatically, in a consistent manner across all trials and within projects, with special attention to adverse events. Review Adverse Events, Concomitant Medication and Medical History glossaries in order that databases can be declared clean and locked according to strict quality standards. 1.Ensure consistency of coding across and within projects with particular emphasis on adverse events. 2.Contribute to and review Validation and Planning (eVAP) coding section. 3.Input into User Acceptance Testing (UAT) specifically for coded term fields. 4.Consult with International Clinical Team Leaders, Medical Advisors, CDMs, CDAs, ICRO Field Monitors, Investigators and Statisticians to resolve coding problems and queries. 5.Manually encode medical and therapy terms not automatically encoded by the data manage-ment system. 6.Generate requests for new Medical and Therapy terms and changes to existing terms, and ensure appropriate changes are made to the dictionaries as agreed. 7.Develop and maintain excellent knowledge of medical and therapy terms using appropriate information tools, e.g. electronic dictionaries, internet etc. 8.Provide assistance if required for Contract Research Organisations (CROs). 9.Provide medical terminology glossaries for review by project team members when required. 10.Participate in initiatives to improve the coding processes and systems. Desired Profile Degree in life sciences, pharmacy, nursing or equivalent relevant experience. Fluent in written and spoken English. 1.Typically 2 or more years experience in drug develop-ment, including 1 or more years in the discipline of data management 2.Understanding of clinical trial methodology, GCP and medical terminology 3.Understanding of coding principles and dictionary phi-losophy specifically with regard to MedDRA and WHODRL. 4.Good computer skills 5.Attention to detail 6.Good organisational and planning skills 7.Good interpersonal and communication skills and the ability to operate effectively in an international envi-ronment 8.Good understanding of physiology, pharmacology, clini-cal study objectives and the drug development process. 9.Good problem solving skills. 10.Ability to collaborate and work as part of a team and without close supervision. 11.Ability to work under pressure and meet timelines. Experience 2 - 4 Years Industry Type Pharma / Biotech / Clinical Research Role Clinical Researcher

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