GPS Safety Data Specialist – Pharmacovigilance

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

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.