Pharmacovigilance System Process Governance Professional
Company
Location
Addlestone, England, United Kingdom
Posted At
6/9/2025
Advertise with us by contacting: [email protected]
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Description
Description
Pharmacovigilance System Process Governance Professional
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 a Pharmacovigilance System Process Governance Professional at Astellas Pharma, you will play a crucial role in ensuring the operational excellence of our Pharmacovigilance (PV) systems and business operations globally. You will be responsible for the development, maintenance, and improvement of our PV IT systems, ensuring compliance with regulatory requirements while enhancing the quality and efficiency of our processes. Your contributions will directly impact patient safety and the effectiveness of our innovative therapies.
Hybrid Working
At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities For This Role
Pharmacovigilance System Process Governance Professional
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 a Pharmacovigilance System Process Governance Professional at Astellas Pharma, you will play a crucial role in ensuring the operational excellence of our Pharmacovigilance (PV) systems and business operations globally. You will be responsible for the development, maintenance, and improvement of our PV IT systems, ensuring compliance with regulatory requirements while enhancing the quality and efficiency of our processes. Your contributions will directly impact patient safety and the effectiveness of our innovative therapies.
Hybrid Working
At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office. You will be part of an inclusive team that works to develop innovative therapies for patients.
Key Activities For This Role
- Translate business requirements into system configuration components to optimize daily operations.
- Ensure safety database system configurations comply with regulatory requirements and align with corporate strategy.
- Oversee the development of Computer System Validation documentation for PV IT systems.
- Maintain the validated status of safety databases and ensure appropriate maintenance of reference data.
- Collaborate with cross-functional teams to identify solutions for new regulatory requirements and process enhancements.
- Extensive experience in maintaining and supporting PV-related IT systems and business processes.
- Strong understanding of Case Management processes and regulatory compliance.
- Proven experience in the pharmaceutical industry, preferably in a PV Process or Operations role.
- Excellent communication and collaboration skills to work effectively across teams.
- High integrity to maintain confidentiality and proprietary information.
- Advanced degree in a science or technology field is preferred.
- Experience managing IT systems and leading teams.
- Familiarity with Lean Six Sigma methodologies for process improvement.
- BS/BA degree or higher in a science or technology field or equivalent.
- This is a full-time permanent role.
- This role is based in the UK office (Addlestone).
- This position follows our hybrid working model. The role requires a blend of home and minimum 1 day per quarter in our UK office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
- A challenging and diversified job in an international setting.
- Opportunity and support for continuous development.
- Inspiring work climate.
Advertise with us by contacting: [email protected]
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