Overview

Join to apply for the Associate Director Pharmacovigilance (PV) Liaison Management role at Astellas Pharma.

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

Description

We pursue innovative science, focusing on the areas of greatest potential and 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 guide 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 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 caregivers, ensuring the medicines we develop continue to provide meaningful outcomes. We support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

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 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.

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.