Pharmacovigilance Safety System Professional

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  • Clinical Development and Medical
  • Bagsværd

Safety Operations (SO) Submission & Support department is looking for a Safety System Professional for an exciting job with a high degree of individual responsibility in a dynamic atmosphere.

About the department

The SO Submission & Support department is part of the Safety Operations Case Management Department in Safety Operations and is thereby one of the functional areas in Global Safety.The department consists of 20 highly engaged team members located in DK and India (13 + 7). The department is responsible for the maintenance, development and continuous improvement of the safety database including system interfaces to critical source systems. In addition, the department is also responsible for the worldwide submission of individual case safety reports to the authorities according to the regulatory timelines. The department works in an informal, fast-paced atmosphere with multiple global stakeholders across Novo Nordisk including safety colleagues from around the world reflecting the increasing demands from numerous clinical trials and regulatory authority requirements.

The position

Using your pharmacovigilance knowledge and experience, your main responsibility is to contribute to the maintenance, development and continuous improvements of the global safety database Argus to ensure the daily case processing of ICSRs. This includes configuration of country specific product licenses, code lists, and clinical trials.

In addition, you will be participating in implementation of changes to the database as well as various projects to provide subject matter expert input regarding regulatory requirements, business processes and requirements to the Global Safety IT systems (e.g. Argus). You will be performing informal and formal testing in Argus, updating standard operating procedures or guidelines and participating in implementation and in end-user training.

Together with your colleagues, you will also be supporting end-users on a daily basis. This entails front-end trouble shooting, incident reporting and identification of improvement initiatives.

Qualifications

You have a relevant university degree e.g. in natural science. You have been working within the field of pharmacovigilance whereby you have gained a good understanding of pharmacovigilance requirements, particularly of the requirements for post-marketing as well as clinical trial cases. In addition, you have experience in analysing and optimising business processes.

Preferably you have experience working with safety databases such as Argus, ArisG or similar. Likewise, experience with IT system testing, impact assessment, stakeholder management and project team work are an advantage. The role requires a structured approach and strong analytical skills including the ability to focus on details and adherence to standards while maintaining a balanced business perspective. The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.

You show commitment, initiative and flexibility and have a good sense of humour. You are open-minded and enthusiastic, a strong team player who can take responsibility and finalise assigned tasks. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.

Working at Novo Nordisk

At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.

The application should be written in English. Qualified candidates will be invited for interview on an ongoing basis.

Contact

For further information please contact Søren Nilaus Præstegaard at +45 3079 4589.

Deadline

17th May 2020

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


Information og data

Denne ledige stilling har jobtypen "Kemiker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 7.4.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Kemiker
  • Bagsværd
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