M.Sc.Pharm., Pharmacovigilance Manager & Deputy QPPV – Human accounts
Jeanette Buskbjerg Poulsen is M.Sc. Pharmacy and has been with Billev Pharma since January 2023 as Pharmacovigilance Manager and Deputy QPPV – Human accounts.
She has more than 14 years of experience with Pharmacovigilance in post-marketing for human medicines and devices at affiliate level within the following areas:
- ICSRs (Case handling, assessment and Follow up with reporters)
- Maintenance and update of Local Pharmacovigilance System Master File (PSMF)
- Training of colleagues and external business partners in PV requirements
- Management of PV activities related to Social Media and Market Research Projects
- Local management and implementation of Risk Minimisation Measures (RMMs)
- Launch of new products
- Literature searches
- SOP writing and maintenance
- Management of training system for PV
In addition, she has 7 years experience with Medical information and experience with Quality (management of complaints).
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
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...
Dyrlæger i life science
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...