Position

Pharmacovigilance Compliance Specialist with expertise in regulatory surveillance

Job description

Job description

Location

Bagsværd, Denmark

Job category

Clinical Development and Medical

   

Are you an experienced pharmacovigilance specialist looking for a dynamic role where you can combine your expertise, collaborative 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.

 

The position

As our new Pharmacovigilance Compliance Specialist, your main responsibilities will be to:
 

  • Continuously monitor sources for regulatory documents of relevance for clinical trial safety, pharmacovigilance and device vigilance , and ensure interpretation and impact assessments of new requirements
  • Support management in ensuring compliance with global regulatory requirements through reporting on trends in the regulatory landscape as well as trends in its implementation via external affairs activities, such as participation in trade organisation s and benchmarking activities
  • Chair the Global Safety regulatory surveillance group
  • Support stakeholders across the organisation with expert advi c e in interpretation of pharmacovigilance legislation
  • Represent Novo Nordisk in relevant external fora within pharmacovigilance

 

You will also play a key role in contributing with ideas for improvement and take part in optimisation 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 in pharmacovigilance, preferably within regulatory surveillance
  • Expert knowledge of pharmacovigilance principles and international regulations
  • Demonstrated experience in leading teams involving cross-functional stakeholders
  • Fluency in both written and spoken English and excellent communication skills
  • High level of structure, attention to detail and quality orientation
  • Natural authority and ability to influence others
  • IT know-how and analytical skills

 

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 tasks. 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.

 

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.

 

Working at Novo Nordisk

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

 

Contact

For further information, please contact Wasim Anwar, phone +4530796766.

 

Application Deadline
June 20th 2021

 

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.

The application should be written in English.

 

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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.