Opportunity to work as Clinical Safety Associate @ Novo Nordisk
Novo Nordisk is one of the world’s most successful pharmaceutical companies and with a great growth potential. Do you want to be part of this?
About the Department
Global Safety Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed products and is responsible for global handling and reporting of adverse event reports. We invest a lot in both professional and personal development and have a thorough individualised development plan for each employee. As part of your job you will receive intensive training in Pharmacovigilance.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
The Job
You will become a member of the safety team which is responsible for processing of ICSRs. You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.
Handling of ICSRs
Perform initial evaluation of spontaneously reported non-serious adverse events including reports from post marketing surveillance studies.
Perform data entry of non-serious adverse events of spontaneous reports; including reports from non-interventional source.
Enter the reported information in the Novo Nordisk safety database – Argus, on the basis of individual case histories, correspondence with affiliates and other departments in headquarters (HQ) and various administrative assignments.
Ensure accurate and consistent coding of all events for non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
Ensure that case narrative comprises correct and appropriate safety information.
Assess the need for follow up information and issue follow up requests for non-serious cases.
Ability to work within strict timelines
Evaluate causality and listedness of Non Serious cases
Ensure maintenance, development and continuous improvement of the Argus safety database.
Maintenance and support of Global reporting rules.
Archiving of cases in Argus.
Qualifications
Bachelor/Master in life science (Health care professional)
Click here to apply
Novo Nordisk is one of the world’s most successful pharmaceutical companies and with a great growth potential. Do you want to be part of this?
About the Department
Global Safety Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed products and is responsible for global handling and reporting of adverse event reports. We invest a lot in both professional and personal development and have a thorough individualised development plan for each employee. As part of your job you will receive intensive training in Pharmacovigilance.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
The Job
You will become a member of the safety team which is responsible for processing of ICSRs. You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.
Handling of ICSRs
Perform initial evaluation of spontaneously reported non-serious adverse events including reports from post marketing surveillance studies.
Perform data entry of non-serious adverse events of spontaneous reports; including reports from non-interventional source.
Enter the reported information in the Novo Nordisk safety database – Argus, on the basis of individual case histories, correspondence with affiliates and other departments in headquarters (HQ) and various administrative assignments.
Ensure accurate and consistent coding of all events for non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
Ensure that case narrative comprises correct and appropriate safety information.
Assess the need for follow up information and issue follow up requests for non-serious cases.
Ability to work within strict timelines
Evaluate causality and listedness of Non Serious cases
Ensure maintenance, development and continuous improvement of the Argus safety database.
Maintenance and support of Global reporting rules.
Archiving of cases in Argus.
Qualifications
Bachelor/Master in life science (Health care professional)
Click here to apply
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