Job for Bachelors or Masters in life sciences as Drug Safety Associate in Novo Nordisk
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Drug Safety Associate
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?
As a Drug Safety Associate you will be part of a young and dynamic team currently consisting of 93 dedicated employees. This role involves archiving of cases in Argus, eexpedited lists: checking daily expedited list. Ensuring accurateness of the list. Detailing the deviations if necessary. Data entry and coding of adverse events of non-serious and serious cases on the basis of individual case histories, correspondence with affiliates and other departments and various administrative assignments. To evaluate causality and listedness in non-serious and serious cases. Compliance with drug safety issues in an environment with complicated and frequently changing regulatory requirements and guidelines. Ability to work within strict timelines generating weekly lists of all cases and analysis replies handled by the team. To be responsible for Periodic Safety Update Report (PSUR) cleanup and other case cleanup activities. Maintenance of MOMs related to case processing and QC feedbacks. Assist with related administrative and procedural activities as required or requested. Ensure all tasks are performed in compliance in accordance to GCP/GMP requirements.
Preferably you have an educational background as a Bachelors or Master’s in life sciences or similar health care profession with a minimum of 2 year experience in a drug safety environment. Fluency in English, written and spoken, is necessary, as the Individual Case Reports are in English. A sound knowledge of medical terminology and computer literacy (Microsoft Office Package and databases) are essential.
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