M.Sc.Pharm., Pharmacovigilance Manager & Regulatory Affairs Officer
Sana Iqbal is M.Sc. Pharmacy and has been with Billev Pharma since June 2015 as Regulatory Affairs & Pharmacovigilance Officer. As of July 2019, Sana holds the position as Pharmacovigilance Manager.
- Works with human medicinal products.
- Experience with the following pharmacovigilance areas:
- Literature searches
- ICSRs
- Update of Pharmacovigilance System Master File (PSMF)
- Maintenance of SOPs
- Writing of PSURs and RMPs
- Signal detection
- Insert and update of products in XEVMPD
- Experience with regulatory affairs activities (preparation and submission of variations etc.)
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...