Nurse, Pharmacovigilance Officer
Louise is B.Sc. Nursing and has been with Billev Pharma since June 2025 as Pharmacovigilance Officer. She has 8 years of experience working as a registered nurse and almost 2 years as an environmental monitoring supporter, working with GMP.
At Billev Pharma she works with post-marketing human medicinal products and has 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.
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