PV Specialist-PV QA Audit
Core
Designing, implementing, and overseeing the Pharmacovigilance Quality Management System (PV QMS) to ensure regulatory compliance and inspection readiness.
Role type
Senior PV Quality Assurance Specialist
Builds
Robust, integrated PV Quality Management System meeting global regulatory standards
Domain
Pharmaceutical industry / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global PV regulations (ICH, FDA, EMA, GVP), Quality & regulatory compliance principles, Cross-functional leadership, CAPA management, Audit strategy, Process improvement, Risk-based auditing, Inspection management
Preferred skills
Stakeholder relationship management, Deviation tracking, Cross-functional CAPA development, Industry trend analysis
Technologies
IT tools for Pharmacovigilance
Responsibilities
Define PV QMS strategy, oversee QMS implementation, support regulatory authority inspections, manage audit logistics and third-party audits, track and resolve CAPAs, establish processes for deviation management, drive process improvements
Seniority
Senior, hands-on IC
