Responsible for pharmacovigilance assignments for clients including in-house pharmacovigilance system.Handling of ISCRs. Medical review of documents for regulatory submission.

Assessment of the clinical safety and efficacy of medicines

Qualified Person for Pharmacovigilance.Part of the management team for the Pharmacovigilance department,Implementation of 2012 PV legislation including set-up of first version of Pharmacovigilance system master file (PSMF)Chair of the Internal safety committee and the Core labelling committee.Strong supporter of crossfunctional collaboration with Regulatory function and Medical Information.Training and supervision of Drug Safety Advisers on medical safety and signal management.Had 8 direct reports from 2002 to 2008

Project safety responsible for clinical trial in cardiac surgery; Review and input to protocols, besides have the primary focus on the safety aspects of the programmesPrimary Safety Responsible for a number of launched products in CNS therapeutic area.

Worked as Medical Director / Safety responsible for several large projectsProject safety responsible for clinical trial for CNS product with development programmes in Analgesics, Epilepsy, Psychiatry and MetabolismSafety responsible for a portefolio of launched products with responsibilities for aggregate reports and signal surveillance