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reference: 4973192

documentId: 4973192

connectionPointId: 7

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stillingsbetegnelse:
Pharmacovigilance Compliance Specialist within Managing Safety Data Exchange Agreement

jobbeskrivelse:

Are you ready to apply your Pharmacovigilance knowledge to manage the global Safety Data Exchange Agreements and be a part of the team supporting the Qualified Person for Pharmacovigilance? Are you looking for a role where you can be part of a truly global workplace, where passion and engagement are met with opportunities for professional development? If you find this exciting and inspiring, you may be our new Compliance Specialist representing Global Safety when establishing Safety Data Exchange Agreements with partners globally.

 

About the department

The position is located in Global Safety Compliance, which is part of the QPPV Office under Global Safety. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibilities of the Global Safety Compliance department are ICSR Compliance Tracking, Safety Data Exchange Agreements, Pharmacovigilance System Master File, Regulatory Surveillance, coordination of PV Audits and Inspections, support to HQ functions and affiliates, including handling of safety in Patient Support Programs, Market Research Programs and Digital Health initiatives. We are 10 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide. 

 

The job

Your main responsibility is to function as an expert with regards to global pharmacovigilance and device Safety Data Exchange Agreements ensuring coherence between regulatory requirements and internal operating procedures and guidelines. This includes supporting the organisation in the negotiation, establishment and maintenance of global Safety Data Exchange Agreements with partners, defining the roles and responsibilities, ensuring timelines and content are manageable for all stakeholders. As a process expert, you are expected to monitor the performance of partners, maintain training of contract owners and support affiliates.  

In addition, you will be involved in and lead cross functional projects, both IT related and continuous improvement of processes within area of responsibilities.

 

Qualifications

You hold a Master’s degree with a scientific background. Extensive knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety is essential. The role requires solid negotiation skills, structure and a strong quality orientation including the ability to focus on details and adherence to standards, while maintaining a balanced business perspective. Very independent and self-promoted initiatives are required to interpret and make valuable decisions regarding Safety Data Exchange Agreements. You are open-minded and enthusiastic and you should have excellent collaboration skills, a high degree of flexibility and be used to delivering according to targets. IT flair and analytical skills are highly desirable. You are fluent in both written and spoken English on a professional level, and feel comfortable working with colleagues from different cultural backgrounds. 

The application should be written in English. 

At Novo Nordisk we use our skills, dedication and drive to help people with diabetes. By working with us you will make an important contribution to this work in a global business environment.

 

Contact

For further information, please contact Mette Stockner, phone +45 3075 6938

 

Deadline

26 April 2019 

 

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/C2411

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