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 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.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
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.
Additional information:
- This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
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.
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