Postmarketing PV Services

Provision and support with Local Qualified Person of Pharmacovigilance (QPPV) services

Pharmacovigilance System Master File (PSMF) development and maintenance

Signal detection and evaluation

Global and Local literature search, review and monitoring

Individual Case Safety Report (ICSR) management

Preparation, updating and submission of Risk Management Plans (RMPs)

Preparation, updating and submission of PSURs/ PBRERs