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Senior/Principal PV Associate

Requistion ID:  1753

Copenhagen, Hovedstaden, DK

Date:  17-Apr-2021

Senior/Principal Pharmacovigilance Associate – GPS Business Support



Are you passionate by utilizing all your operational and quality skills making a real difference for Patient Safety? Are you solution oriented and eager to drive process improvements/innovation to find new smarter ways of working? We are looking for a talented colleague to take an active part in adding value to Patient Safety and relevant stakeholders at global level.


As a function within Research & Development, Global Patient Safety (GPS) is responsible for the safety data management, surveillance and benefit-risk assessment of all Lundbeck’s pharmaceutical products, including pipeline and established products. We consist of more than 100 dedicated colleagues who strive to successfully deliver comprehensive safety knowledge working together in a dynamic, diverse global team across Denmark, Singapore and the US.

The GPS Business Support department is a team of 7 specialised pharmacovigilance professionals responsible for driving the Lundbeck QPPV Office, the PV Quality Management System, PV regulatory intelligence and providing support to Local Patient Safety activities in affiliates.


Your job and key responsibilities

You will be a member of our dedicated QPPV Office team and contribute to a wide variety of operational tasks related to the maintenance of our Global PSMF, management of CAPAs, coordination and management of audits and inspections, and maintenance of oversight of the PV system performance etc. You will lead the operational tasks related to CAPA management and act as operational expert on the CAPA management system (SAP). You will drive follow-up activities with CAPA plan owners and be responsible for creation of various overviews/data outputs. You will also be contributing to the operational maintenance of our Quality Management System and providing support to the Local Patient Safety function.


Your daily work will require close teamwork with QPPV Office colleagues and other colleagues in GPS Business Support, as well as collaboration with stakeholders from across GPS, other R&D functions and other parts of the organization, affiliates and service providers.

You will work in a highly dedicated and professional international environment. The job requires diligence and attention to details while at the same time ability to find innovative, creative and pragmatic solutions and multitasking, often requiring you to proactively reach out to colleagues.


We offer

This is an excellent opportunity to influence the further development of Global Patient Safety in Lundbeck, and we offer an interesting job in an ever more demanding area of the pharmaceutical industry in a global environment, with attractive and flexible working conditions and good career opportunities.



Our preferred candidate has the following personal and professional qualifications:

  • Your educational background is not important, but previous experience with quality-related operational/administrative activities is required
  • Self-driven and service-minded with solid quality mindset and good understanding of stakeholder management
  • Solution oriented “do’er” with Lean mindset and ability to drive innovation / finding new smarter ways of working
  • A true team player with excellent collaboration and communication skills
  • Data-driven mindset with excellent command of MS Office (Excel, PowerPoint, Word), Visio, Sharepoint and SAP would be an advantage
  • Experience from regulated industries (e.g. pharmaceuticals) and/or pharmacovigilance/patient safety would be an advantage


Further information

For further information, please contact Bina Kramhøft Schack at bink@lundbeck.com or +45 3083 2239.

Your application and CV should not be sent via email.

We also recommend that you have a look at our website, LinkedIn and Instagram.


Your application

Please click on the apply button. Applications must be received no later than 23 May 2021.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.
Read more at www.lundbeck.com/global/about-us/progress-in-mind
Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.