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:
Are you ready to take the lead in shaping global pharmacovigilance strategies? At Astellas, we’re looking for a dynamic and experienced professional to join our team as an Associate Director – Pharmacovigilance Liaison Management. This is a unique opportunity to play a key role in ensuring the safety of our products and the health of patients worldwide.
You’ll be at the heart of our global PV operations, working closely with internal teams, external partners, and regulatory authorities. If you’re passionate about compliance, operational excellence, and cross-functional collaboration, we’d love to hear from you.
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:
As Associate Director, you will:
- Lead the development and execution of PV Process Liaison Management strategies across global and regional teams.
- Ensure PV requirements are embedded in clinical and non-interventional study protocols and safety reporting plans.
- Oversee regulatory reporting and ensure full compliance with global health authority guidelines.
- Manage product quality complaint processing and exchange activities.
- Represent PV Process during audits and inspections, ensuring readiness and compliance.
- Build and maintain strong relationships with vendors, including onboarding, performance monitoring, and issue resolution.
- Design and deliver effective training programs for PV staff and external stakeholders.
- Collaborate with cross-functional teams including Regulatory Affairs, Clinical, Medical Affairs, QA, and Supply Chain.
- Lead and develop a high-performing team (1–5 FTEs) within the PV Process Interface Management function.
- Drive continuous improvement and contribute directly to regulatory compliance and operational success.
Essential Knowledge & Experience:
- A strong background in Pharmacovigilance, Regulatory Affairs, Quality Assurance, or Clinical Development.
- Solid understanding of global PV regulations and guidelines (e.g., ICH, CFR 21, FDAAA, EU GVP, JP regulations).
- Demonstrated experience with GxP Quality Management Systems and PV data management.
- Excellent communication and interpersonal skills, with the ability to work across cultures and functions.
Preferred Knowledge & Experience:
- Experience leading multidisciplinary teams in a global matrix environment.
- Strategic thinking and strong decision-making skills.
- Experience managing complex projects and budgets.
- Willingness to travel as needed.
Education:
- University degree in life sciences or related field.
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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