Associate Director, Pharmacovigilance Quality Management, Global Patient Safety
argenx
argenx seeks an Associate Director of Pharmacovigilance Quality Management to lead operational implementation of the Global Patient Safety quality management system. The role encompasses audit oversight, training program development, procedure management, and continuous improvement initiatives across a multi-regional organization.
Responsibilities
- Coordinate and manage GVP audit, inspection readiness activities, and regulatory responses
- Develop, implement, and maintain comprehensive pharmacovigilance training programs
- Lead deviation management, root cause analysis, and corrective/preventive action implementation
- Manage pharmacovigilance agreements, procedural documents, and compliance monitoring
- Drive quality performance metrics development and monitor third-party contractual obligations
Requirements
- Bachelor's degree in pharmacy, nursing, healthcare, or related life-science field
- Minimum 10 years pharmaceutical or biotech industry experience
- At least 5 years pharmacovigilance or drug safety experience
- Proven experience establishing and managing pharmacovigilance quality systems and teams
- Experience preparing for and responding to regulatory inspections
- Fluency in written and spoken English
- Strong organizational and cross-functional collaboration skills
L'offre d'emploi a été publiée il y a 7 jours
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