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stillingsbetegnelse: Specialist within pharmacovigilance

jobbeskrivelse:

Would you like to be a driving force in ensuring highest safety and lowest possible risk to patients that use Novo Nordisk products? And would you like to be part of a highly skilled and advanced headquarter safety function? If you find this interesting you may be our new specialist within pharmacovigilance.

 

About the department

Safety Operations is a functional area within Global Safety situated in Bagsværd, Denmark. Global Safety is an organisation of more than 400 highly professional people with a background within Health Science. The core responsibility of Safety Operations is to assess patient safety from a medical and scientific point of view based on individual reports of adverse events in clinical trials and identified product quality issues relating to Novo Nordisk products.

 

The position

As a Specialist in Safety Operations, your primary responsibility is to ensure fulfilment of global regulatory requirements to the collection, evaluation and reporting of safety information in clinical trials and non-interventional studies. Your main tasks will therefore be to assess the impact of new regulatory requirements to established safety processes, facilitate decision making and drive initiatives for process improvement and/or to secure regulatory compliance.

Likewise, you will be evaluating the consequences of disease conditions, interpreting diagnostic results and identifying differential diagnosis based on individual adverse events reported on development products from clinical trials. Furthermore you will drive the review of clinical trial and non-interventional study protocols to ensure adequate collection of relevant safety information according to regulatory requirements and Novo Nordisk procedures. The responsibility includes training of monitors & investigators globally with regards to safety reporting and chairing cross functional groups serving as knowledge sharing, planning and problem-solving groups within Global Safety for clinical trials.

In relation to product quality issues and potential recall situations, you bring broad and in depth understanding of medical concepts and diseases when assessing the potential risk to patients.

You will be working independently and in collaboration with a team of highly skilled, committed and enthusiastic colleagues. Assuming responsibility, communicating information and taking action will be essential part of you work day. You will have close collaboration and interaction with other functional areas in Novo Nordisk including Global Development and Regulatory Affairs and you will be an important contributor in the Novo Nordisk organisation.

 

Qualifications

Medical Doctor, Master in Pharmacy, Veterinarian or equivalent medical and scientific background. You have extensive experience within pharmacovigilance and/or experience from clinical development within the pharmaceutical industry.

As a person you are responsible, well-organised and adjust quickly to changes. You have a high degree of flexibility, a good sense of urgency and cope well under pressure while still maintaining overview and constructive approach towards the challenges you are facing. You have a team oriented personality, a high degree of cross-cultural awareness and are good at establishing professional relations. You are fluent in English both written and spoken (company language).

 

Working at Novo Nordisk

At Novo Nordisk your skills, commitment and ambition help us change lives for diabetes patients for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

 

Contact

For further information, please contact Sacha Mette Honig (+45 3075 1266).

 

Deadline

23. November 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