Astellas is a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing 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 healthcare 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.

The Opportunity

As a Pharmacovigilance Manager at Astellas Pharma, you will be responsible for the development and maintenance of excellence in Global PV Audit and Inspection management and process improvement, to ensure oversight over the PV Quality Management System, ensuring inspection readiness, as well as compliance with all applicable worldwide pharmacovigilance regulations.

Ensure oversight over the compliance, consistency, and quality of Pharmacovigilance processes by supporting internal audits, deviation investigations, and driving continuous improvement of the PV System, so that PV represents best-in-class practices. Collaborate with PVQA and relevant PV and non-PV Astellas partners in support of global PV Audit and Inspections.

Key Responsibilities

• Lead the development and maintenance of excellence in Global PV Audit and Inspection management.
• Ensure compliance and quality of Pharmacovigilance processes through internal audits and continuous improvement initiatives.
• Collaborate with internal and external partners to support global PV audits and inspections.
• Drive the implementation of best practices in audit and inspection management.
• Support the creation and execution of the PV Non-conformance/CAPA system.

Essential Knowledge & Experience

• Demonstrable experience in Pharmacovigilance, Regulatory Affairs, or Quality Assurance.
• Strong analytical skills with a focus on compliance and quality.
• Excellent communication and collaboration skills to work effectively with diverse teams.

Preferred Experience

• Direct experience in supporting non-conformances/CAPAs.
• Familiarity with global pharmacovigilance regulations and standards.

Education

• Bachelor’s Degree in a relevant field or equivalent experience.

Astellas is 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.