Pharmacovigilance Liaison Manager
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 passionate about patient safety and regulatory excellence? At Astellas, we’re looking for a skilled and motivated professional to join our Global Pharmacovigilance (GPV) team as a Manager – Pharmacovigilance Liaison Management.
In this role, you’ll be a key link between internal teams, external partners, and health authorities, ensuring that our safety data collection and reporting processes meet the highest standards. You’ll help shape global PV strategies and contribute directly to the safety profile of our products.
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:
- Apply your 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 such as DSOs, Regulatory Affairs, Clinical and Medical Affairs, QA, and license partners.
- Maintain accurate documentation and track submission activities using ALCOA principles.
- Escalate issues and support root cause analysis for any compliance deviations.
- Contribute to inspection readiness and may act as a subject matter expert (SME).
- Support regulatory compliance by ensuring timely and accurate submissions of periodic safety reports.
Essential Knowledge & Experience:
- A 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 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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