PHARMACOVIGILANCE AUDITOR
Core
Lead and coordinate GVP audits (process, system, document) for pharmaceutical clients, acting as an external consultant for quality assurance and improvement of pharmacovigilance systems.
Role type
Senior Pharmacovigilance Auditor (Lead/Co-Auditor)
Builds
Audit strategies, risk assessments, audit programs, and corrective/preventive action plans for PV systems.
Domain
Pharmaceutical industry / Regulatory Compliance / Quality Assurance
Deliverable
client delivery
Required skills
GVP auditing, PV system assessment, regulatory compliance assessment, risk assessment, CAPA management, audit strategy design, documentation and reporting
Preferred skills
Quality Assurance, GVP compliance, multi-country PV activities
Technologies
GVP guidelines, global/local PV regulations
Responsibilities
Execute operational tasks and technical delivery for PV audits; Coordinate and perform GVP audits as lead or co-auditor; Conduct mock inspections and assist during Health Authority inspections; Assess PV systems and processes including interfaces with partners; Manage corrective/preventive action plans; Provide advice on GVP practices and legislation compliance; Design audit strategy and risk assessment programs.
Seniority
Senior, hands-on IC with leadership responsibilities