GPS Operations Specialist – Safety Data (Denmark)

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

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