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Company Novartis Healthcare Pvt. Ltd.
Website www.novartis.com
Eligibility B.Sc/B.Pharma/MBBS/M.S/M.D
Experience 3 - 6 yrs
Location Across India
Job Role Clinical Researcher
JOB SUMMARY:
Company profile :
Job Description:
Company Novartis Healthcare Pvt. Ltd.
Website www.novartis.com
Eligibility B.Sc/B.Pharma/MBBS/M.S/M.D
Experience 3 - 6 yrs
Location Across India
Job Role Clinical Researcher
JOB SUMMARY:
Company profile :
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes us one of the most rewarding employers in our field.
Provide support to the IMS Department in the single case medical review and associated activities as needed such as Periodic Safety Update Report (PSUR), coordinating the management of large datasets for analysis purposes, responses to Health Authorities, within agreed timeframes and to a high standard of accuracy, in compliance with DS&E business rules, standard operating proce-dures and global and local regulatory requirements. 1. Performs single case medical review in the safety database or on line listings Of Oncology marketed products. 2. Author or co-authors the medical sections of PSURs including literature review and analysis of known and potential risks defined in the RMP. 3. Assists in the preparation of other safety documents, as needed/required, including Annual Safety Update Reports (ASR) , DSURs , Core Data Sheets (CDS) and IBs.
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