Senior Pharmacovigilance Quality Manager
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
As the Senior Pharmacovigilance Quality Manager, you will be responsible for developing and maintaining excellence in global PV Quality, Compliance, Audit and Inspection management, Process Improvement, and Data Governance. You will ensure oversight of the PV Quality Management System, maintain inspection readiness, and ensure compliance with worldwide pharmacovigilance regulations. Collaborating with key PV and non-PV stakeholders across Astellas, you will align with company-wide standards, oversee compliance and quality of PV processes, conduct internal audits and deviation investigations, analyze and report on key metrics, and drive continuous improvement to establish best-in-class PV practices.
Hybrid Working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.
Responsibilities:
- Establish and implement tools to monitor compliance, quality metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis for continuous improvement.
- Lead internal assessments, support external audits and regulatory inspections, mentor PV staff, and implement best practices for audit and inspection management in collaboration with Quality Assurance teams.
- Oversee Corrective & Preventive Actions (CAPA) and deviation processes, provide guidance on development and implementation, track progress, collect evidence, and coordinate effectiveness checks.
- Drive continuous process improvements by analyzing audit/inspection findings, identifying quality risks, and leading initiatives to enhance PV compliance and operational efficiency.
- Develop and maintain training programs related to audit/inspection readiness, compliance, and quality performance indicators, ensuring alignment across global PV teams and affiliates.
- Support data governance initiatives to ensure high-quality data for decision-making, assess downstream implications of data activities, and align ongoing initiatives with compliance requirements.
Essential Knowledge & Experience:
- Extensive experience in the pharmaceutical, biotechnology, or related industry.
- Strong background in Pharmacovigilance, Regulatory Affairs, or Safety Quality Assurance, with expertise in establishing safety quality system standards that impact multiple departments and management levels.
- Proven experience in people or project management within a highly matrixed, multicultural global setting, demonstrating facilitation, negotiation, problem-solving, and conflict resolution skills.
- Deep knowledge of global safety regulations for both marketed and investigational products, including ICH, CFR 21, FDAAA, EU GVP Module, and JP regulations, along with expertise in process management, standards, training, and IT functions across the pharmaceutical product life cycle.
- Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.
- Expertise in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools such as SharePoint, Microsoft Office, Access, and Project.
Preferred Experience:
- Experience with data-driven problem-solving methodologies (e.g. lean, six sigma).
Required Qualification:
- BA or BS degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in The Netherlands.
- This position follows our hybrid working model. The role requires a blend of home and a minimum 1 day per week in our Leiden office. Flexibility may be required in line with business needs.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
