Bio

Global PV leader with over 19 years’ experience leading all facets of PV operations in healthcare sector. Demonstrated expertise in risk management plans (RMPs), periodic safety update reports (PSURs), post-marketing PV commitments, signal detection, PASS, PV inspections, GVP and GCP audits, Quality Management System, ARGUS/ARISg/Veeva safety databases, XEVMPD database and safety study protocols. Strategic thinker with proven capacity to implement effective EU QPPV and PV strategies in adherence with industry best practices, trends, and legislation requirements to meet shared and individual goals. Adept at biological, biopharmaceuticals products, including vaccines, OTC, generics, cosmetics, and medical devices. Articulate and refined communicator establishing robust relationships with all levels of management.