Ofertas de empleo de Farmacéuticos en Dinamarca (HOVEDSTADEN)
Senior Compliance Professional In Global Safety
Clasificación del trabajo:Profesionales científicos e intelectuales : Profesionales de la salud : Otros profesionales de la salud : Farmacéuticos. Arbejde, der forudsætter viden på højeste niveau inden for pågældende område : Arbejde inden for sundhedsområdet : Andet sundhedsarbejde : Farmaceutarbejde.
Descripción de la oferta de trabajo:
-?Regulatory -?Denmark - Bagsværd Are you ready to apply your Pharmacovigilance (PV) 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 Professional securing high quality standards in our work to provide the safest products to patients. About the department The position is located in Global Safety Compliance which is part of the Qualified Person responsible for Pharmacovigilance (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 Individual Case Safety Report (ICSR) Compliance Tracking, Safety Data Exchange Agreements (SDEAs), Pharmacovigilance System Master File, Regulatory Surveillance, coordination of PV Audits and Inspections, and support to HQ functions and affiliates in safety handling of Patient Support Programs and Market Research Programs. We are 10 colleagues with different professional backgrounds ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide. The position Your main responsibility is to function as an expert with regards to global pharmacovigilance and device Safety Data Exchange Agreements to ensure timely preparation and content accuracy. This includes supporting the organisation in the negotiation and establishment of global SDEAs with partners concerning timelines, roles and responsibilities regarding exchange and content of safety information related to Novo Nordisk products. In addition, you will be responsible for the maintenance of global SDEAs ensuring they are in compliance with both external and internal requirements. 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. 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 degree in Medical, Biological, Pharmaceutical Science (e.g. Medicine, Pharmacy, Veterinary) or related disciplines and have proven relevant experience. Extensive knowledge of pharmacovigilance principles and international regulatory requirements regarding drug safety is essential. The role requires analytical 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 Pharmacovigilance 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. 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. Working at Novo Nordisk 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 at +45 3075 6938 or Klaus Bitsch-Jensen at +45 3075 0655. Deadline 24 August 2017.
Servicio de empleo de origen:AMS, Servicios Públicos de Empleo, Dinamarca.