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stillingsbetegnelse: Pharmacovigilance Safety System Professional

jobbeskrivelse:

Safety Operations (SO) Submission & Support department is looking for a Safety System Professional to 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 16 highly engaged team members located in DK and India (12 + 4). 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

Your main responsibility is to contribute to the maintenance, development and continuous improvements of the Global Safety database Argus. This includes business configuration e.g. country specific product licenses, code lists, clinical trials and auto scheduling rules for regulatory reporting. You will, among other things, be analysing changes in the pharmacovigilance requirements from regulatory authorities, performing impact assessments and gap analysis towards the Argus database and its related business processes and interfaces.
 

In addition you will be participating in 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, 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, and have experience working with safety databases preferably Argus or Aris Global. You have been working within the field of pharmacovigilance and you have experience in analysing and optimising business processes.

Experience with IT system testing, impact assessment, stakeholder management and project team work is an advantage. The role requires 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.

The desired candidate has a structured approach to tasks, shows commitment, initiative and flexibility and has 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.

 

Contact

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

 

Deadline

29^th October 2018

 

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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: NOVO NORDISK A/S

source: DK-STAR