Safety Operations Adviser
- Quality
- Denmark - Bagsværd
Are you interested in making a difference in patient safety for Novo Nordisk? – Then you may be our new Safety Operations Adviser.
About the department
We are looking for two Safety Operations Advisers to join our Safety Operations (SO) Advisers team from 01 January 2014.
You will be part of a team of academic employees with different scientific backgrounds and cultural diversity with 6 nationalities represented.
The SO Advisers Department belongs to Safety Operations, one of the functional areas in Global Safety. The core activity of the department is to perform the medical evaluation and impact analysis on patients’ safety of adverse event reports and product quality issues of our product portfolio to ensure compliance with regulatory requirements globally. You can look forward to a position where you can use your medical knowledge and analytical skills.
Novo Nordisk has a broad development portfolio in diabetes, haemostasis and inflammation with several products in the approval phase and new submissions this year. Safety information is assessed already during the development phase of a drug and is maintained after the regulatory approval throughout the whole lifecycle of the product.
The Job
As a Safety Operations Adviser you will be primarily responsible for the medical interpretation and evaluation of adverse events based on the individual medical case histories reported from our clinical trials and marketed products. It is your job to make sure that the tight timelines for global regulatory safety reporting are met. Moreover, you will analyse the potential impact on patients’ safety of any product quality issues from our product portfolio. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional collaboration, and international communication will be part of your busy workday. You will provide safety input to clinical trial protocols, train and supervise other colleagues on medical evaluation to ensure high quality of data, train monitors and investigators, participate in continuous quality improvement projects.
Qualifications
You have a Master degree in Medicine, Pharmacy or Veterinary with knowledge of clinical pharmacology and pathophysiology. Experience in pharmacovigilance is a must. You speak and write English fluently. You are good at communicating, planning and coordinating multiple activities. You have excellent cooperative skills and a high degree of flexibility. As a person you are dynamic, eager to learn new processes, careful with your tasks and have a positive attitude to challenges. You must be able to work against tight deadlines, have a good sense of urgency and cope well under pressure still maintaining your good sense of humour.
All training necessary for managing the job will be provided. The application should be written in English.
Contact
For further information about the job please contact Claudia Pierleoni-Nielsen at+45 3075 9671.
Deadline
4 October 2013.
- Quality
- Denmark - Bagsværd
Are you interested in making a difference in patient safety for Novo Nordisk? – Then you may be our new Safety Operations Adviser.
About the department
We are looking for two Safety Operations Advisers to join our Safety Operations (SO) Advisers team from 01 January 2014.
You will be part of a team of academic employees with different scientific backgrounds and cultural diversity with 6 nationalities represented.
The SO Advisers Department belongs to Safety Operations, one of the functional areas in Global Safety. The core activity of the department is to perform the medical evaluation and impact analysis on patients’ safety of adverse event reports and product quality issues of our product portfolio to ensure compliance with regulatory requirements globally. You can look forward to a position where you can use your medical knowledge and analytical skills.
Novo Nordisk has a broad development portfolio in diabetes, haemostasis and inflammation with several products in the approval phase and new submissions this year. Safety information is assessed already during the development phase of a drug and is maintained after the regulatory approval throughout the whole lifecycle of the product.
The Job
As a Safety Operations Adviser you will be primarily responsible for the medical interpretation and evaluation of adverse events based on the individual medical case histories reported from our clinical trials and marketed products. It is your job to make sure that the tight timelines for global regulatory safety reporting are met. Moreover, you will analyse the potential impact on patients’ safety of any product quality issues from our product portfolio. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional collaboration, and international communication will be part of your busy workday. You will provide safety input to clinical trial protocols, train and supervise other colleagues on medical evaluation to ensure high quality of data, train monitors and investigators, participate in continuous quality improvement projects.
Qualifications
You have a Master degree in Medicine, Pharmacy or Veterinary with knowledge of clinical pharmacology and pathophysiology. Experience in pharmacovigilance is a must. You speak and write English fluently. You are good at communicating, planning and coordinating multiple activities. You have excellent cooperative skills and a high degree of flexibility. As a person you are dynamic, eager to learn new processes, careful with your tasks and have a positive attitude to challenges. You must be able to work against tight deadlines, have a good sense of urgency and cope well under pressure still maintaining your good sense of humour.
All training necessary for managing the job will be provided. The application should be written in English.
Contact
For further information about the job please contact Claudia Pierleoni-Nielsen at+45 3075 9671.
Deadline
4 October 2013.