stillingsbetegnelse: PV Lead Auditor

jobbeskrivelse:
- Quality - Denmark - Bagsværd Are you experienced working in pharmacovigilance, and are you passionate about quality? Are you maybe looking for a career change? Then you may be our new PV auditor. Do you want to be part of one of the world’s most successful pharmaceutical companies? Do you burn to contribute to modern and ethical clinical research that makes a difference for millions of people? Do you have a strong quality mindset and do you dream of a job with high level of responsibility, exposure and interaction with people across many different cultures? About the department As a PV auditor in Novo Nordisk, you will be part of the Quality R&D Audits in Corporate Quality. The department is located in Bagsværd, at the Headquarters in Denmark, and has the global responsibility for performing audits of clinical trials throughout all development phases, as well as pharmacovigilance audits worldwide. Our primary goal is that our audits shall drive compliance in the areas of PV and GCP. This means ensuring patients’ rights and safety, data integrity and ensuring that Novo Nordisk stays compliant with the applicable regulations. We are dedicated to teamwork, sharing audit best practices within the department and with auditors in other areas, striving to develop a consistent auditing approach at a world-class level. Currently, the entire Quality R&D Audits department consists of 28 members divided in 3 teams (two in Bagsvaerd, Denmark and one in Bangalore, India). The PV Audit team counts 4 members currently. The job As an auditor you will have a high level of responsibility, and you can make a great impact in the organisation. Your key responsibility is to perform PV audits at Novo Nordisk affiliates as well as PV external parties, with whom Novo Nordisk has PV agreements. You should expect approximately 80-100 annual travel days outside Denmark. We require that you are professionally mature and able to work independently. It is expected, that you are analytical and pragmatic. As an auditor you will interact and communicate effectively with external and internal stakeholders at all organisational levels, and across many different cultures. Qualifications You hold a university degree in natural or pharmaceutical sciences. You already have experience as PV auditor, or you have worked in a drug safety department for at least 7 years and you have a documented experience in all aspects of pharmacovigilance. Additional GCP auditing experience will be an advantage. You have high ethical standards and are committed to the overall aim of ensuring ethical conduct, safety of trial subjects and data integrity. You have good knowledge of good pharmacovigilance practice (GVP) and good documentation practice (GDP) requirements, and you have the ability to understand and interpret the applicable standards in the field. During your professional life you have certainly developed the “eye for detail”, but you put things into perspective and see the “big picture”. You are an open-minded person, with cultural awareness and excellent communication skills, who likes to be in daily contact with different stakeholders around the world. You thrive in a dynamic and busy environment with changing priorities. Since most of the audits are conducted outside Denmark, you must be fluent in English both orally and in writing. Please make your application in English. At Novo Nordisk, decisions and actions are based on their impact on society, the environment and on their potential to generate profit. That makes for a responsible culture with a healthy and engaging working environment. Contact For further information, please contact Liliana Cristina Hansen at +45 307 50964. Deadline 5 February 2016.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark