GPS Operations Specialist, Pharmacovigilance

Biopharma Asia

København

Hybrid

DKK 687,000 - 945,000

Full time

31 hours ago
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Job summary

Lundbeck is seeking a Specialist Safety Data Professional in Global Patient Safety Operations DK to ensure high-quality safety data across developmental and marketed products. You will process adverse event reports, code MedDRA terms, and support clinical trial safety and safety data management in an international pharma setting.

The role emphasizes independent work, strong PV knowledge, and collaboration within GPS Operations DK, based in Copenhagen, Denmark.

Qualifications

  • Degree in health or natural sciences (pharmacy/public health/biology or related).
  • Experience with pharmacovigilance and adverse event case processing.
  • Experience with clinical trial safety activities including reporting and narrative writing.
  • Strong digital skills and ability to work with safety databases and tools.
  • Independent, structured, adaptable and collaborative work style.

Responsibilities

  • Process and assess adverse event reports per internal PV procedures and global regulations.
  • Perform medical coding using MedDRA and ensure high-quality safety data management.
  • Support trial-related safety activities including reporting and narrative writing.
  • Develop and maintain process docs (SOPs, work instructions) and assist in inspections/audits.

Skills

Pharmacovigilance
Quality mindset
Independent worker
Adaptable
Team collaboration

Education

Health or natural sciences background

Tools

Safety databases

Job description

Lundbeck is seeking a Specialist Safety Data Professional in Global Patient Safety Operations DK to ensure high-quality safety data across developmental and marketed products. You will process adverse event reports, code MedDRA terms, and support clinical trial safety and safety data management in an international pharma setting.

The role emphasizes independent work, strong PV knowledge, and collaboration within GPS Operations DK, based in Copenhagen, Denmark.

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