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Pharmacovigilance Associate - GPS Business Support

 
Requistion ID:  2857
Location: 

Copenhagen, Hovedstaden, DK

Date:  28-Apr-2022
 

Pharmacovigilance Associate – GPS Business Support

 

Description

Are you passionate by utilizing all your operational and quality skills making a real difference for Patient Safety? Are you solution oriented and have an eye for finding new smarter ways of working? We are looking for a self-driven, talented colleague who is willing to go that extra mile to support your colleagues, thereby 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 11 specialised pharmacovigilance professionals responsible for driving, the PV Quality Management System, PV regulatory intelligence, the Lundbeck QPPV Office and providing support to Local Patient Safety activities in affiliates.

 

Your job and key responsibilities

You will be a member of our QMS, Intelligence and Training team and contribute to a wide variety of operational tasks related to the maintenance of our Quality Management System as well as the management of our PV Intelligence process.

You will be the key driver of operational tasks related to the day-to-day management of our QMS system, including ensuring correct formatting and properties of the documents, management of workflows, etc. You will drive follow-up activities with deviation owners and be responsible for maintaining overview of both QMS documents and deviations. You will be a key contributor to our PV Intelligence function with day-to day operational activities, incl. mailbox management, screening and filing/archiving of information and maintenance of various overviews/trackers.

You will also be contributing to the operational maintenance of our other activities on an ad hoc basis, including PSMF management, management of CAPAs, coordination and management of audits and inspections, maintenance of oversight of the PV system performance and providing support to the Local Patient Safety function.

 

Your daily work will require close teamwork with QMS, Intelligence and Training Team 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.

 

 

 

Qualifications

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” thriving with routine tasks and with Lean mindset and ability to find new smarter ways of working
  • A true team player with excellent collaboration and communication skills in English (oral and written)
  • Data-driven mindset with excellent hands-on command of MS Office (Word, Excel, PowerPoint), Visio and Sharepoint
  • Experience from regulated industries (e.g., pharmaceuticals) and/or pharmacovigilance/patient safety would be an advantage

 

Further information

For further information, please contact Deputy QPPV & Sr. Director, Head of GPS Business Support 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 30 May 2022.

 

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn.