Qualified Person - PV, EU
Core
Serves as the European Union (EU) and/or UK Qualified Person for Pharmacovigilance (QPPV) or Deputy QPPV for selected clients, ensuring regulatory compliance and overseeing drug safety services.
Role type
Senior regulatory compliance lead (Pharmacovigilance)
Builds
Regulatory-compliant pharmacovigilance services for developmental and market-authorized compounds
Domain
Life sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
client delivery
Required skills
EU/UK QPPV qualification, extensive EU-specific PV experience, PV regulatory inspection experience, safety writing, signal detection, literature surveillance, budget management, stakeholder management, process improvement, client proposal development
Preferred skills
Team lead coordination, complex data analysis, medical coding dictionary knowledge, data interoperability expertise
Technologies
Pharmacovigilance databases
Responsibilities
Fulfill EU QPPV/Deputy QPPV role per EU Directive 2001/83/EC, contribute to scientific safety services, oversee national contact persons, promote good practices and training, present safety services to potential clients, manage scope of work and budget, determine methods for new assignments
Seniority
Senior, hands-on IC with leadership responsibilities