Local Qualified Person for Pharmacovigilance
Pharmacovigilance Intelligence
Pharmacovigilance Unit start up
Writing and adapting of Standardized Operating Procedures (SOPs)
In-company trainings and training programs
Medical Information
Preparation of Risk Management Plans (RMPs), including follow-up of local actions
Pharmacovigilance for Orphan Drugs. Intensive Pharmacovigilance Programs
Writing and/or adapting to local regulations all Periodic Reports (PSURs/PBRERs, CRP, DSURs)
ICSRs Management
Local and International Literature Screening
Audits (with native local language speaking auditors) and preparation for inspections (focused on local requirements).
Out of office support (24/7)
Pharmacovigilance agreements between companies
Updating of leaflets and information for the patient