Marie Jordan Loft
M.Sc. Pharmaceutical Sciences, Pharmacovigilance Manager
Marie Jordan Loft has more than 8 years of experience with Pharmacovigilance in post-marketing for human medicines and vaccines at headquarter level within the following areas:
- ICSRs (Case handling, assessment and Follow up with reporters)
- Maintenance and update of Pharmacovigilance System Master File (PSMF)
- SOP writing and maintenance
- Signal detection
- Writing of PSURs
- Management of training system for PV
- SDEA negotiation
- Literature searches
- Training of colleagues in PV requirements
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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