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stillingsbetegnelse: Safety Submission Expert

jobbeskrivelse:

Pharmacovigilance Safety Submission Expert in Global Safety

Would you like to be part of a dynamic team and involved in securing safe products for patients? Do you enjoy working as part of a team and do you have experience with pharmacovigilance and medicinal terminology, then we may have the job for you.

 

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 operating and maintaining the Global Safety database Argus and ensuring submission of single safety cases to secure worldwide regulatory compliance.

 

The position

Your main responsibility is to ensure that Individual Case Safety Reports (ICSRs) are made available on a daily basis for affiliates and Health Authorities worldwide according to regulatory requirements and internal procedures.

As a Safety Submission Expert you will be involved in supporting Argus users within the area of regulatory reporting requirements applicable to ICSRs. You will be working in our Global Safety database according to written procedures and in close collaboration with your colleagues in Denmark and Bangalore. You will be working in an international environment where you will be interacting with colleagues in Safety Operations, affiliates, and other stakeholders in submission related matters including submission failures. You will also be involved in ensuring development and maintenance of our processes concerning submission of ICSRs and will be expected to actively contribute to the identification of areas for improvement.

 

Qualifications

Preferably, you have an education as nurse, pharmaconomist, medical secretary, laboratory technician/assistant and have knowledge of medicinal terminology. You are a proficient user of IT systems (including databases and web solutions). You have experience within the area of pharmacovigilance, preferably with submission of ICSRs.

You are a team player and like knowledge sharing. You have a structured approach with a sense for details. You have a high quality mind set and like to work according to procedures.

You are service minded and enjoy working in a dynamic environment with changing priorities and short deadlines. English proficiency is a must and you like to work across cultures and skill types.

 

Working at Novo Nordisk

In Novo Nordisk it is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.

If you would like to know more about how it is to work at Novo Nordisk A/S, you can find more information here: https://www.novonordisk.com/careers/working-at-novo-nordisk.html

The application should be written in English.

 

Contact

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

 

Deadline

11-Nov-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