General Information
Job Advert Title PV Controlled Documents QMS Professional Location Poland Function/Business Area Regulatory Affairs and Pharmacovigilance Employment Class PermanentDescription
Global PV Controlled Documents Professional 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:
The PV Controlled Documents Professional is responsible for contributing to the development and implementation of the overall strategy to ensure excellence in Process and Procedural Document (PD) Management (e.g., Policies, SOP, WI, Job Aids etc.), in compliance with all applicable worldwide pharmacovigilance regulations and Astellas internal and industry standards.
Coordinates and oversees the development of sustainable business processes and process documentation, to support and improve operational performance, and ensure oversight over and regulatory compliance of, the Pharmacovigilance Quality Management System.
Drives the Implementation of a continuous procedural document-improvement process for PV (including any (IT) tools and systems), and compliance with periodic review of documents and appropriate revision.
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:
- Responsible for global oversight over and coordinating the maintenance of all (global, regional and local) PV procedural documents (e.g. Policies, SOP, WI, Job aids, conventions etc.), including translations into local language as required.
- Responsible for establishing and maintaining methodologies for the management and maintenance of the PV PD structure (PV document pyramid) and road map including maintaining compliance with periodic review of PDs.
- In collaboration with function heads, team leads, process owners and SME’s, identify deviations in performance from the standards and implement strategies for corrective action to ensure that PV processes and PDs are consistent with regulatory (e.g. GVP, GCP, local PV) requirements, Astellas policies and best-in-class practices.
- Maintain oversight over any identified duplication, discrepancies, conflicts or gaps related to PV PDs, and propose, coordinate and implement changes in collaborations with the process owners and functional management, ensuring the implementation of a continuous quality document-improvement process for PV.
- Proactively monitor the environment to identify opportunities for improvement, maintain awareness of regulatory issues impacting PV business processes, and support the process owners with implementation of new legislation and initiating changes into quality documents.
Essential Knowledge & Experience:
- Solid experience in pharmaceutical, biotechnology, or related industry, including establishing standards in support of the quality systems, especially as they impact and influence multiple departments and levels of management.
- Direct pharmacovigilance experience working in controlled document systems and writing of Procedural Documents to defined standards is a pro
- Demonstrated strong project leadership skills in a multicultural global setting, with emphasis on facilitation and negotiation.
- Strong project management skills and experience.
- Excellent English communication skills and experience working in global, cross-functional teams.
Preferred Experience:
- Solid understanding of Pharmacovigilance (PV) and drug safety regulations (e.g. GVP, GCP).
- Experience in managing controlled documents and using document management systems (e.g. Veeva Vault, SharePoint).
- Familiarity with quality management systems and compliance standards.
- Strong attention to detail with the ability to identify gaps, overlaps, or inconsistencies in documentation.
- Proactive mindset with skills in process improvement and continuous quality enhancement.
Education:
- University degree 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.
#LI-Warsaw #LI-Hybrid #LI-LG1
Report job
