Amalie Gjøl Almegaard

Amalie Gjøl Almegaard
B.Sc. Nursing, Master of Arts in Educational Psychology, Pharmacovigilance Officer

Amalie is B.Sc. Nursing and has been with Billev Pharma since February 2024 as Pharmacovigilance Officer. She has 2 years of experience working as a registered nurse and 1 year of experience with teaching nursing. At Billev Pharma she works with post-marketing human medicinal products and have the following areas of work:

  • Processing ICSRs (case handling, assessment and follow up with reporters)
  • Reporting ICSRs to regulatory authorities and SDEA partners
  • Worldwide and local literature search screening for adverse events and other relevant safety information
  • Signal detection reports
  • Benefit-risk evaluation reports
  • Art. 57 (xEVMPD)
  • Supporting other PV staff with the creation and quality control of safety reports
Services

Registration

We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier. 

Pharmacovigilance

We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.

Translations

We offer high quality medical & pharmaceutical translations into and from several European languages.

Electronic submission

We are equipped to assist with any type of electronic submission and maintenance of your electronic file.

Special medicines areas

Herbal medicinal products, strong vitamin and mineral products, medicinal gasses, euphoriant substances, etc.

GDP & GMP Services

We offer full time and part time responsible person (RP) function and qualified person (QP) function.

Latest News

Simple solutions in a complex PV environment

We are happily handling an increasing number of pharmacovigilance responsibilities for our clients in a complex pharmacovigilance environment. Our team of pharmacovigilance experts is now organised in three different fields – Human Accounts, Veterinary Accounts, and...

Dyrlæger i life science

I det nyeste nummer af Pharma kan du læse om vores kollega Charlotte Lindorf Eriksen og hendes arbejde med pharmacovigilance som dyrlæge i Billev Pharma Pharma nr. 3 2023—Side 14 (ipaper.io). Charlotte er netop blevet forfremmet til Head of Pharmacovigilance og har...