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About Astellas



Astellas is a progressive health partner, delivering value and outcomes where needed.

Description



Pharmacovigilance Liaison Manager



Astellas pursues innovative science, focusing initially on areas of greatest potential and developing solutions where patient need is high, often in rare or under-served disease areas and life-threatening or life-limiting diseases and conditions.

Astellas works directly with patients, doctors, and healthcare professionals to ensure patient and clinical needs guide development activities at every stage. The global vision for Patient Centricity is to support innovative health solutions through a deep understanding of the patient experience.

The Opportunity



Astellas is looking for a skilled and motivated professional to join the Global Pharmacovigilance team as a Manager – Pharmacovigilance Liaison Management. In this role, you will be a key link between internal teams, external partners, and health authorities, ensuring safety data collection and reporting processes meet the highest standards.

Hybrid Working



Astellas offers a hybrid working solution, allowing time to connect with colleagues in person at the office and the flexibility to work from home.

Key Responsibilities

• Apply pharmacovigilance expertise to support PV data needs from clinical studies and post-marketing programs.
• Ensure PV requirements are included in study protocols and Market Research Programs.
• Coordinate and execute DSUR and SLL submissions and distributions in line with global reporting rules.
• Build strong working relationships with health authorities and internal stakeholders.
• Maintain accurate documentation and track submission activities using ALCOA principles.
• Escalate issues and support root cause analysis for compliance deviations.
• Contribute to inspection readiness and act as a subject matter expert (SME).
• Support regulatory compliance by ensuring timely and accurate submissions of periodic safety reports.

Essential Knowledge & Experience

• Solid background in Pharmacovigilance, Regulatory Affairs, Quality Assurance, or Clinical Development.
• Strong understanding of global safety regulations and health authority requirements.
• Experience with GxP Quality Management Systems and adverse event reporting.
• Ability to work independently and manage cross-functional projects.
• Strong communication, leadership, and negotiation skills.

Preferred Knowledge & Experience

• Hands-on experience with aggregate safety report submissions and tracking.
• Familiarity with DSUR and SLL processes and documentation standards.

Education/Qualifications

• University degree in life sciences or related field.

Additional Information

• This is a permanent role based in the Global Capability Centre in Warsaw, Poland, with hybrid working and the expectation for some office presence.

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.