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
En inspirerende teamdag
Hvordan kan det være, at nogle ser begyndelser (bryllup), mens andre ser slutninger (begravelse), når 4 sorte limousiner kommer kørende i kortege på tværs af vejen? Kan du lære at holde hovedet, håbet, humøret & modet oppe? JA, vi nåede 9 opbyggelige øvelser på 5...
Are you lacking the capacity or qualification to perform an audit?
At Billev Pharma we have a team of qualified lead auditors within GVP, VGVP, GMP and GDP. Last year our audit team conducted more than 10 remote pharmacovigilance audits and 10 onsite GDP audits of warehouses. We conduct remote and onsite audits within the EU as well...
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...