Specialist, GPS Operations DK

Cari; København; Hybrid; DKK 687,000 - 945,000; Full time

Job summary

Lundbeck is seeking a Specialist in GPS Operations DK to ensure high-quality safety data across clinical development and marketed products. You will process AE reports in line with internal procedures and global PV regulations, coding with MedDRA and supporting pharmacovigilance activities.

You will work with a global, collaborative team in a safety-focused environment, contributing to data quality, trial safety activities, and cross-functional safety projects in Copenhagen.

Qualifications

• Experience in pharmacovigilance and adverse event case processing.
• Understanding PV and GCP regulations and guidelines.
• Experience with clinical trial safety activities and reporting.
• Strong digital skills with safety databases and tools.

Responsibilities

• Process and assess adverse event reports per PV procedures and global regulations.
• Perform MedDRA coding and contribute to safety data management.
• Support trial safety activities including reporting and narrative writing.
• Develop and maintain process docs and participate in safety teams.

Skills

Pharmacovigilance

Adverse events

MedDRA coding

Quality mindset

Safety data management

Clinical trial safety

PV databases

GCP knowledge

Education

Health or natural sciences degree

Tools

PV databases

Safety systems

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 . 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 lundbeck/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.