M.Sc. Pharm., Regulatory Affairs Manager
Bettina Jespersen is MSc. in Pharmacy and has been with Billev Pharma since May 2020 as Regulatory Affairs Officer. While studying MSc. in Pharmacy at the University of Copenhagen she worked for Billev Pharma as a student worker. As of March 2023 Bettina will hold the position as Regulatory Affairs Manager.
- 4 years of experience within Regulatory Affairs handling procedures within the EU and Pharmacovigilance activities for human medicinal products.
- Experience with national procedures, MRP and DCP and other regulatory issues.
- Experience with compilation of electronic submission (eCTD and NeeS).
- Experience with xEVMPD reporting.
- Experience with proofreading of product information and mock-ups.
In addition, she is fluent in Portuguese BR as she lived in Brazil for more than 20 years.
We are well-equipped to provide regulatory advice, discuss strategy and/or compile the registration dossier.
We have a team of highly qualified pharmacovigilance employees with expertise in all aspects of pharmacovigilance.
We offer high quality medical & pharmaceutical translations into and from several European languages.
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.
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...
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...
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...