Etheo PV

Providing expert PV consultancy services to the pharma industry. Experience with clinical trial, named patient, compassionate use and post-authorisation portfolios in pharma, CRO and consultancy environments, in organisations ranging from the very small to the very large. Experience in all regions worldwide, including emerging markets. Specific areas of interest: QMS development, oversight and management Affiliate network development, oversight and management PV Agreements - drafting, negotiating, reviewing, developing templates and systems CAPA Mgmt - deviations process as well as audit and inspection Regulatory Intelligence Inspection and Audit preparation Metrics development and oversight Training, PV and leadership/mgmt training General PV Operations Stakeholder and client management Please note Etheo PV is the trading name for Dr Rebecca Godfrey, a self-employed pharmacovigilance consultant