Specialist, GPS Operations DK

Lundbeck; København; On-site; DKK 687,000 - 945,000; Full time

Job summary

Lundbeck is seeking a Specialist Safety Data Professional in Global Patient Safety Operations (GPS) DK to ensure high-quality safety data across development and marketed products. You will process adverse event reports, code medically using MedDRA, and support trial safety activities within an international pharmaceutical setting.

The role emphasizes rigorous PV compliance, collaboration across GPS, and development of safety documentation, contributing to patient safety with a strong quality

Qualifications

• Educational background in health or natural sciences such as pharmacy, public health, biology, or related field.
• Experience with pharmacovigilance and adverse event case processing, including PV regulations and GCP guidelines.
• Experience with clinical trial safety activities, including reporting and narrative writing.
• Strong digital skills and ability to work with safety databases and systems.

Responsibilities

• Process and assess adverse event case reports in line with internal procedures and PV regulations.
• Perform medical coding using MedDRA and contribute to high-quality safety data management.
• Support clinical trial safety activities, including trial-related reporting and narrative writing; participate in cross-functional safety teams.
• Develop and maintain process documentation (SOPs, work instructions, steering documents) and support audit activities.
• Contribute to patient safety in Lundbeck's clinical development and marketed products.

Skills

Pharmacovigilance

Adverse event processing

Quality mindset

Patient safety

Digital skills

Education

Health or natural sciences degree

Tools

Safety databases

Job description

Specialist, GPS Operations DK

Global Patient Safety Operations

Are you passionate about patient safety and ensuring high-quality safety data? Do you have experience in pharmacovigilance and enjoy working with adverse event reporting and clinical trial safety? You could be our next Specialist Safety Data Professional in Global Patient Safety Operations (GPS) at Lundbeck.

Your new role

As our Specialist in GPS Operations DK, you will play an important role in ensuring high-quality safety data and supporting patient safety across Lundbeck's clinical development activities and marketed products.

You will be responsible for processing adverse event reports in accordance with internal procedures and global pharmacovigilance (PV) regulations, while collaborating with colleagues across Global Patient Safety.

Your key responsibilities will include:

• Process and assess adverse event case reports in accordance with internal procedures and global PV regulations, ensuring accuracy, completeness and timely reporting.
• Perform medical coding using MedDRA and contribute to high-quality safety data management.
• Support clinical trial safety activities, including trial-related reporting and narrative writing, and participate in cross-functional safety teams.
• Develop and maintain process documentation, including SOPs, work instructions and steering documents, and support inspection and audit activities when needed.
• This is an opportunity to contribute directly to patient safety while developing your expertise in a collaborative and international pharmaceutical environment.

Your future team

Global Patient Safety (GPS) is part of Lundbeck's R&D organization and is responsible for safety surveillance and benefit-risk assessment across our development pipeline and authorized products. We are more than 90 colleagues working globally to protect patients and ensure compliance with regulatory requirements.

You will join Global Patient Safety Operations DK, a team of eight dedicated colleagues within our broader Safety Operations organization of more than 30 Safety Data Professionals across Copenhagen and Singapore.

Our culture is hands-on, curious and transparent. We value collaboration, empathy and knowledge-sharing, and we support each other in delivering high-quality work while maintaining a positive and enjoyable working environment.

The position is based in Copenhagen, Denmark.

What you bring to the team

We are looking for a colleague with experience in pharmacovigilance and adverse event case processing, combined with a strong quality mindset and an interest in patient safety.

We imagine that you bring:

• An educational background in health or natural sciences, such as pharmacy, public health, biology or a related field.
• Experience with pharmacovigilance and adverse event case processing, including an understanding of relevant PV and Good Clinical Practice (GCP) regulations and guidelines.
• Experience with clinical trial safety activities, including clinical trial reporting and narrative writing.
• Strong digital skills and the ability to work efficiently with safety databases and other relevant systems and tools.

You work independently, exercise sound judgement and know when to seek guidance in complex situations. You are structured, adaptable and comfortable managing changing priorities while maintaining high quality standards. Most importantly, you enjoy collaborating with others and contribute to an open, supportive and positive team environment.

We also encourage candidates with less experience to apply. Depending on the selected candidate's qualifications and experience, the position may be adjusted in terms of job title, responsibilities and salary level.

Our promise to you

Lundbeck offers an inspiring workplace and innovative culture, where our curiosity, accountability and adaptability enable us to transform lives. We want to go faster and further on addressing the big unmet needs of people living with brain disorders. We offer rewarding careers with a mix of exciting tasks and development opportunities that are balanced with initiatives focused on your well-being.

We need every brain in the game, and at Lundbeck, 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.

Annual base salary range: 687 000 - 944 900 DKK gross.

At Lundbeck, we are committed to fair and transparent pay. Please note that the final base salary within the stated range will be based on relevant qualifications, skills, competencies, and level of proficiency as well as internal pay equity.

For candidates considered for a position at a lower job level, the job title, responsibilities and applicable salary range will be adjusted accordingly.

This job ad is intended for individuals seeking a career opportunity with Lundbeck.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.