Pharmacovigilance Compliance Specialist in Global Safety Compliance

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Bagsværd

  • Clinical Development and Medical
  • Bagsværd

Are you an experienced pharmacovigilance specialist looking for a dynamic role where you can combine your knowledge, project management skills and natural drive for improvement? Do you want to be part of an organisation where passion and engagement are met with opportunities for professional development? If you find this exciting and inspiring, you may be our new Pharmacovigilance Compliance Specialist.

About the department

You will be working within Global Safety Compliance, which is part of the QPPV Office under Global Safety, located in our headquarters in Bagsværd. Global Safety is globally responsible for handling adverse events, monitoring product safety and 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, and coordination of pharmacovigilance audits and inspections. Furthermore, we provide support to headquarter functions and affiliates, including compliance advice and support regarding handling of safety in Patient Support Programmes, Market Research Programmes and Digital Health initiatives.

You get the opportunity to join a high-performing team of 10 employees with different professional backgrounds. We use our differences to create novel ideas and high-quality solutions to ensure support and continuous improvement to the Qualified Person for Pharmacovigilance in Novo Nordisk, Global Safety and affiliates worldwide.

The position

As Pharmacovigilance Compliance Specialist, you will act as the subject matter expert for stakeholders in headquarter and affiliates across Novo Nordisk with regards to handling of safety in Patient Support Programmes, Market Research Programmes and Digital Health initiatives. This includes pre-assessment of vendors and preparation, content accuracy and negotiation of all Safety Data Exchange Agreements with partners. As a process expert, you are also expected to monitor the performance of partners, maintain training of contract owners and support affiliates.

Furthermore, you apply your knowledge of pharmacovigilance and device vigilance requirements and guidelines to help stakeholders in headquarter and affiliates across Novo Nordisk find solutions to complex problems. You will also play a key role in contributing with ideas for improvement and lead optimization projects within Global Safety. Besides your main responsibilities, you will be able to form the role and assignments based on your professional experience and interest.

Qualifications

  • Master’s Degree in biomedical sciences
  • A minimum of 8 years of experience within pharmacovigilance, preferably from a similar position within the pharmaceutical industry
  • Expert knowledge of pharmacovigilance principles and international regulations
  • Demonstrated experience in leading complex projects involving cross-functional stakeholders
  • Strong negotiation skills, structure and quality orientation
  • High attention to detail while at the same time being able to see the bigger picture
  • Fluency in both written and spoken English and excellent communication skills are required
  • IT know-how and analytical skills are highly desirable

As a person, you are open-minded with a high degree of flexibility. You are truly passionate and enthusiastic about working in a highly regulated compliance department with complex projects. You have excellent collaboration skills and can easily navigate on all levels in the organisation.

Furthermore, we expect you to work independently and drive a variety of tasks with responsibility for delivering according to targets. Last, but not least, you have a natural drive to always find ways of improvement, without compromising on quality.

The application should be written in English.

Working at Novo Nordisk

At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to help us strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us and make the most of your talent.

Contact

For further information, please contact Eirik Quamme Bergan, phone +45 3079 3513

Deadline

November 25th.
Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase.

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 chronic 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.


Information og data

Denne ledige stilling har jobtypen "Kemiker", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Bagsværd.

Jobbet er oprettet på vores service den 17.11.2020, men kan have været deaktiveret og genaktiveret igen.

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Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Kemiker
  • Bagsværd
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