Cand.Scient.Pharm., Pharmacovigilance Manager & QPPV – Human accounts
Laura Sparving is M.Sc. in Pharmaceutical Sciences and has been with Billev Pharma since January 2019 as Pharmacovigilance Manager. Laura was appointed QPPV for our human pharmacovigilance system in February 2023.
Laura has more than 10 years’ experience with pharmacovigilance in post-marketing and clinical trials for human products within the following areas:
- Signal detection
- Writing of aggregated reports including Periodic Safety Update Report (PSURs), Development Safety Update Report (DSUR) and Risk Management Plan (RMP)
- Update of labelling documents
- Chair of Safety Management Teams
- Literature surveillance
- Individual case review
- Safety monitoring in clinical trials
- Investigator meetings
- Safety database upgrade
- Data entry of ICSRsIn addition, she has experience with regulatory affairs.
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...