M.Sc.Pharm., Senior Pharmacovigilance Manager
Lisbeth Bonde Jensen holds a M.Sc. Pharmacy and a Pg. Diploma in Pharmacovigilance. She has been with Billev Pharma since April 2016 and now holds the position as Senior Pharmacovigilance Manager.
Lisbeth has more than 15 years of experience in pharmacovigilance from the pharmaceutical industry working with originator products as well as generics within the following areas:
- PV for clinical trials and post-marketing.
- Quality Management System for pharmacovigilance in HQ and affiliates.
- PV audits and inspections.
- Trained GCP and GVP lead auditor.
- Delegated Qualified Person (GMP).
- GMP audits and inspections.
On top of this, Lisbeth has several years of experience from the GMP area with manufacturing and QA.
Lisbeth partly retired in July 2022 and now works part time as Pharmacovigilance Lead auditor.
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
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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...