Vigilance Expertise: Pharmacovigilance inspection unit: A deficiency

13 rue Camille Desmoulins
92130 Issy Les Moulineaux
Tel :
+33(0)1 58 04 27 85
Fax :
+33(0)1 58 04 23 00
Mail :
[email protected]
Vigilance Expertise:
Pharmacovigilance data management: MedDRA, ARIS, Safety-Easy and Argus coding
Medical assessment (adverse event encoding, assessment of the relatedness according the
French method (Begaud) and the WHO method, assessment of the expectedness and
Writing case narratives
Drafting periodic reports of pharmacovigilance (CSRs, DSUR/PSURs, AddCO, PGR)
Regulatory dossiers audits
Monitoring of scientific literature (Pubmed, Reactions, Pascal, Embase-Medline)
Preparing variation applications (DMI)
Drafting internal procedures
Pharmacovigilance inspection unit:
Prepare for a GPvP inspection
Summary of Pharmacovigilance Systems (SPS)
Pharmacovigilance System Master File (PSMF)
Detailed Description of Pharmacovigilance Systems (DDPS)
A deficiency in pharmacovigilance systems, practices or processes that adversely affects the
rights, safety or well-being of patients or that poses a potential risk to public health or that
represents a serious violation of applicable legislation and guidelines.
Our goal is to provide expertise that fit into your strategy and contribute to your success
NOVA BIOTECH-PHARM CONSULTING -13 rue Camille Desmoulins - 92130 Issy Les Moulineaux-France
Tel : +33(0)1 58 04 27 85
Fax : +33(0)1 58 04 23 00-Mail : [email protected]