Safety Surveillance Principal Specialist - Tresiba® team

JOB DESCRIPTION:

- Pharmacovigilance - Denmark - Bagsværd Is drug safety important to you? Are you excited by digging into information to find answers? Do you want to play a key role in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk products? You may be our new colleague in Safety Surveillance Insulin & Devices. About the department Safety Surveillance Insulin & Devices is a department within Global Safety and is situated in Bagsværd, Denmark. Our team of dedicated and skilled professionals has global responsibility for the surveillance of all safety information for Novo Nordisk’s insulin products that are currently marketed or under development. The job The position as a Safety Surveillance Principal Specialist is open for immediate placement. You will be responsible for the ongoing safety surveillance of one or more products. This responsibility includes critical analysis and medical evaluation of the emerging safety data, establishment of the product safety profile during development and maintenance of the labelling for marketed products, and communication about the benefit-risk assessment. You may also be safety representative in cross-functional teams and contribute to development of clinical trial protocols and clinical trial reports. Your job responsibilities may also include chairing a drug safety committee and communication with external parties related to clinical safety monitoring, such as Data Monitoring Committees. You will work independently and in collaboration with a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, communicating information and taking action will be essential parts of your work day. You will have a close collaboration and interaction with other functional areas in Novo Nordisk, especially the clinical development team and regulatory affairs team. Qualifications Preferably you have a medical doctor (MD) degree. Alternatively you may have a university degree within Natural Sciences (DVM, M.Sc. Pharm. or equivalent). You have a minimum 5 years of experience from the pharmaceutical industry in the medical/clinical development or drug safety departments. A solid understanding of medical concepts, disease processes, scientific methodology, drug development and data analysis is very important, and documented scientific training (e.g. PhD) or experience from interactions with regulatory authorities will be an additional advantage. As a person you are ethical, responsible, well-organised, strong communicator, are able to work under pressure when needed and able to make independent decisions regarding drug safety issues. You are a strong driver and a dedicated team player who thrives in a global environment of continuous development, and you are good at establishing contact and collaborating with stakeholders. You must be fluent in English, both written and spoken and be an experienced user of MS Office (Excel, PowerPoint, Word, and Outlook). At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information please contact Poul-Martin Haahr at +45 3075 4082 Deadline 25 February 2016.

Work hours:

• Without entering work hours
  

Requirements

source: https://www.ec.europa.eu/eures

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