Pharmacovigilance Quality Management Professional
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.
Learn more at Astellas.com .
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
- This position is field based in the Netherlands, with approximately 80% travel within the assigned territory.
- Type of role full-time permanent.
- Location Netherland office (Leiden).
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- Responsible for developing and maintaining excellence in global Pharmacovigilance Audit and Inspection Management and Process Improvement, ensuring oversight of the Pharmacovigilance Quality Management System, inspection readiness, and compliance with all applicable worldwide pharmacovigilance regulations.
- Ensure oversight of the compliance, consistency, and quality of Pharmacovigilance processes by supporting internal audits, managing deviation investigations, and driving continuous improvement of the PV System, ensuring best in class practices.
Role and Responsibilities
- Audit & inspection support. Provide coordination and support for local affiliate audits, partner audits, and regulatory PV inspections, including preparation, hosting, and onsite assistance when required.
- Inspection operations. Contribute to inspection operational activities, serving as back office lead, document manager, scribe, and coordinating responses to regulatory and partner risk assessment questionnaires.
- CAPA & deviation oversight. Oversee PV CAPAs and deviations, guiding development, implementation, evidence collection, effectiveness checks, and KPI reporting to QPPV and management.
- Process improvement. Conduct internal assessments, performs trend analyses of audit/inspection findings, identifies systemic quality risks, and drives continuous improvement initiatives across PV processes.
- Cross functional collaboration. Work closely with PV functions, Global and Regional QA, and other stakeholders to implement best practices and ensure consistent global quality standards.
- Regulatory readiness. Ensure ongoing inspection readiness, contributes to inspection documentation (e.g., ACO), supports 24 hour EU QPPV availability testing, and acts as backup for key PV quality roles.
Required Qualifications
- Bachelor’s degree or equivalent.
- Extensive previous experience in pharmaceutical, biotechnology, or related industry,
- Significant experience in Pharmacovigilance, Regulatory Affairs or Quality Assurance,
- including establishing standards and metrics in support of quality systems especially as they impact and influence multiple departments and levels of management.
Preferred Qualifications
- Direct pharmacovigilance experience supporting non-conformances/CAPAs (Corrective and Preventive Action).
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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