About Astellas:
At Astellas we are making treatments that matter to people.
We are tackling the toughest health challenges putting the patient at the heart of every move we make.
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 have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.
We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.
From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.
The Opportunity:
As the System & Process Governance Lead, you will be responsible for overseeing and improving system configuration management processes within the Pharmacovigilance (PV) Transformation & Technology team.
Your key responsibilities will include managing global mailbox procedures, training team members on these procedures, supporting the creation of team metrics through root cause analysis, and maintaining business and technical requirements for the Safety Database. Additionally, you will conduct impact analysis, review change requests, and support audit, inspection, and non-conformance activities, with a focus on continuous improvement and process excellence.
Hybrid Working:
At Astellas we recognize 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; optimizing the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- Lead the implementation and maintenance of robust system configuration management processes to support current and future configuration changes.
- Develop and manage global mailbox procedures within the System & Process Governance team, including setting up and decommissioning mailboxes.
- Create and deliver training for IQVIA team members on global mailbox procedures.
- Manage oversight of activities performed by IQVIA team members in the global mailbox.
- Support the creation of metrics for the Transformation & Technology team, using root cause analysis to identify trends and process improvements.
Essential Knowledge & Experience:
- Strong understanding of global mailbox procedures within the System & Process Governance team.
- Excellent knowledge of the pharmaceutical industry with proven expertise in the field.
- Proven ability to manage and maintain business requirements for the Safety Database, translating them into technical requirements.
- Extensive experience with Pharmacovigilance systems, with proven expertise in the field
- Proven ability to perform testing and implementation verification processes.
- Strong understanding of Audit & Inspection processes, including support for Non-conformance & CAPA activities.
- Fluent in written and spoken business English.
Education:
- Bachelor's degree or equivalent.
Additional information:
- This is a permanent, full-time position.
- This position is based in the Netherlands.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in the Netherlands office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
What We Offer:
- A challenging and diversified job in an international setting
- Opportunity and support to continuous development
- Inspiring work climate
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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