Pharmacovigilance is the area within Global safety and responsible for processing ICSRs.
Global safety has a outstanding track-record in case processing. You will join a team of highly motivated employees, responsible for the safety of the patients.
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.
Qualification
Bachelor/Master in life science (Health care professional)
Contact
For further information, please contact Shivshankar B L at +91 08033549288
Deadline 21 September 2014
Global safety has a outstanding track-record in case processing. You will join a team of highly motivated employees, responsible for the safety of the patients.
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.
Qualification
Bachelor/Master in life science (Health care professional)
Contact
For further information, please contact Shivshankar B L at +91 08033549288
Deadline 21 September 2014
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