M.Sc.Pharm., Head of Regulatory Affairs
Karen Jensen is M.Sc. in Pharmacy and has been with Billev Pharma since June 2018 as a Regulatory Affairs Manager. In January 2020 Karen was promoted to Head of Regulatory Affairs.
- Has more than16 years of experience from the Danish Medicines Agency as a Special Adviser.
- Has also 3 years of experience from Regulatory Affairs at a Global Danish Pharmaceutical Company handling procedures both within and outside the EU.
- Has wide experience with new national procedures, MR and DC procedures, renewals, variations, referrals and other regulatory issues.
- Experience with both human and veterinary medicinal products.
- Former speaker at postgraduate courses for pharmacists (marketing authorizations in general, variations, referrals etc.).
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...