stillingsbetegnelse: Quality and Compliance Professional

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you ready to apply your Pharmacovigilance knowledge together with your personal skills, dedication and ambition to manage the overview of regulatory requirements from local health authorities worldwide? 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 Quality and Compliance Professional securing high quality standards in our work to provide the safest products to patients. About the department The job is located in the GS Quality and Compliance department within the QPPV office in 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 responsibility of the Quality & Compliance department is to ensure that Global Safety is consistent and meets both external and internal requirements, including legal compliance and customer expectations. We are 13 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk. Due to the nature of the job you will be working with stakeholders globally. The job Your main responsibility is to ensure timely preparation and content accuracy of all global safety data exchange agreements (SDEAs) signed by Global Safety. You also exert an advisory function with regards to Novo Nordisk pharmacovigilance and device vigilance SDEAs including those for affiliates worldwide and external parties. This includes negotiation, establishment and maintenance of global SDEAs with affiliates and partners concerning timelines, roles and responsibilities regarding exchange and content of safety information related to NN products. Together with your colleagues you also support the management of the Global Rules Management System. This entails daily interaction with affiliates and review of data entered by affiliates to secure accuracy and consistency. You will exert an advisory function for affiliates and for stakeholders across Global Safety and must ensure that new requirements are being communicated to relevant Global Safety areas and anchored in processes and procedures as applicable. You will be expected to ensure coherence between requirements and internal operating procedures and guidelines and you will report and advice on requirements within area of responsibility to Global Safety and management on a regular and ad hoc basis. These responsibilities include data trending and analysis. Furthermore, you will be responsible for providing training to enable our stakeholders to achieve quality and compliance. Qualifications You hold a Master degree or have proven relevant experience. Extensive knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety is essential. The role also requires excellent analytical skills 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 Pharmacovigilance agreements and contracts. You are open-minded and enthusiastic and you should have good co-operation skills, a high degree of flexibility and are used to delivering according to targets. You are fluent in both written and spoken English on a professional level, and feel comfortable working with colleagues from different cultural backgrounds. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Nakisa Harmes on +45 3079 1616.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark