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

Design and conduct of Phase IV studies and post-authorization safety studies (PASS)

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