Senior QPPV Office Professional

Requistion ID: 5333

Location:

Copenhagen, Danish Capital Region, DK

Senior QPPV Office Professional

Are you passionate about optimizing processes and finding innovative solutions? Do you thrive on using your operational skills, digital expertise, and quality mindset to drive efficiency?

And would you like to apply these competences in a highly specialised function that collaborates across Lundbeck and with external partners with an aim to safeguard the health of the patients taking our medicines and ensure compliance?

If so, we have an exciting opportunity for you – as our newQPPV(Qualified Person for Pharmacovigilance) Office Professional in Lundbeck’s Global Patient Safety (GPS) Quality & Compliance (Q&C) function.

Your new role – why is this a great opportunity?

As a member of our QPPV office, you’ll play a crucial role in ensuring the safety of our patients and compliance of our pharmaceutical products. You’ll be responsible for maintaining oversight while also contributing to practical, forward-thinking solutions, along with contributing to further development of the foundation for Lundbeck’s pharmacovigilance (PV) system. Your main responsibilities will be on supporting audits and inspections, CAPA (corrective actions/preventive actions) and deviations, as well as global training in the PV system.You’ll 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 often requiring you to proactively reach out to colleagues.

Here’s what you’ll be doing:

Efficiency Champion: Streamlining processes and identify opportunities for improvement.

• You will contribute to the practical coordination and management of audits and inspections.

• You will also contribute to the day-to-day management and oversight of our Quality Management system (QMS), the maintenance of our Pharmacovigilance System Master File (PSMF) and oversight of the PV system performance.

Quality Advocate: Uphold high standards and contribute to our commitment to patient safety.

• You will ensure the day-to-day management of deviations and CAPAs, incl. providing support to and continuous follow-up with the owners and authors across the organization.

• You will also drive the day-to-day management of our training system, ensuring timely creation of training plans and distribution of training to relevant staff.

Digital Innovator: You will leverage technology to enhance our pharmacovigilance practices.

• You will support bringing us towards optimizing our digitalization with an intuitive professional outlook, no coding needed, but we hope you will help translating existing processes to more intuitive digital platforms.

Your daily work will involve a broad interface and close collaboration with both colleagues in your new team, across the GPS organization and other Research & Development (R&D) functions, as well as affiliates and service providers.

You will work in a highly dedicated and professional international environment. Your role will involve finding innovative, pragmatic solutions and proactively collaborating with colleagues, with good opportunities for evolving the role further as well as for ensuring your personal development, depending on your interests.

Your future team

GPS Q&C is part of the GPS organization within Lundbeck R&D. GPS is responsible for the safety (pharmacovigilance) of patients using our medicinal products globally. We consist of approximately 100 dedicated colleagues working together in one global team across Denmark, Singapore, and the US.

The GPS Q&C department is responsible for ensuring adherence to regulatory requirements, quality standards, and best practices in PV. We develop and implement metrics, maintains oversight of the Lundbeck PV system, and collaborates cross-functionally to maintain compliance. We are located in Valby (Copenhagen), Denmark, and supports all of our GPS sites. You will join a department with 8 great colleagues who take pride in driving results and upholding high quality standards to safeguard our patients. Our days are rarely the same. We count on each other, respectfully challenge and support each other on a daily basis and value an informal tone and a light-hearted working environment.

What you bring to the team

While your specific educational background is not decisive, we do expect you to have a formal higher education (M.Sc. level or equivalent) – this could be within pharmacy, quality or other regulated / structured scientific discipline, e.g. library science, logistics or similar.

We operate in a highly regulated and specialized environment so attention to detail and a quality mindset are essential. Curiosity and ability to learn are of greater importance than formal experience yet bringing some understanding of / experience from patient safety and quality (or similar areas e.g. clinical operations or regulatory affairs) is an advantage.

You are self-driven and digital savvy. Creating coherent structures that work in practice comes naturally to you, as does a certain level of pragmatism combined with an eye for details. You take ownership for your tasks, and proactively follows up and follows through on your commitments. You are a collaborative team player with a strong customer focus. Moreover, you are a good communicator and hold great stakeholder management skills. Technical writing skills (in business English) would be a bonus for us.

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

You can also learn more about us at www.lundbeck.com or by following us on LinkedIn or Instagram (@h_lundbeck).

Apply now

Can you see yourself in this role? We want to hear from you. Does this sound like your dream job, but you’re not sure if you meet all the requirements? We still want to hear from you!

Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Bina Kramhøft Schack, Sr. Director GPS Quality & Compliance, Deputy QPPV at +45 40832239 or bink@lundbeck.com . Applications must be received by 31 May 2024.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve. Read more about our commitment at www.lundbeck.com/global/about-us/our-commitment/diversity-and-inclusion .

#EveryBrainInTheGame

This job ad is intended for individuals seeking a career opportunity with Lundbeck. We engage with recruitment and search firms where needed on the basis of a written agreement, and we do not accept unsolicited requests of any kind. If you work as a recruitment consultant, you are kindly instructed to refrain from contacting Lundbeck or the hiring manager directly with suggested candidates. If you violate this policy, you do so at your own risk and for your own account, and Lundbeck will not assume any liability nor pay any associated fees resulting from such violation.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.

About Lundbeck

Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.

Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.