Pharmacovigilance System Process Governance Professional

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

A leading pharmaceutical company is seeking a Pharmacovigilance System Process Governance Professional to enhance PV systems and ensure regulatory compliance with an impactful focus on patient safety. This full-time role offers an opportunity to work in a hybrid environment, collaborating with a dedicated team to develop therapies that address critical health challenges.

Benefits

Opportunities for development and growth

Challenging and diverse job in an international setting

Inspiring work environment

Qualifications

• Extensive experience with PV-related IT systems and processes.
• Strong understanding of Case Management and compliance.
• Experience in the pharmaceutical industry, especially in PV processes or operations.

Responsibilities

• Ensure operational excellence in Pharmacovigilance (PV) systems.
• Develop and maintain PV IT systems and ensure regulatory compliance.
• Collaborate with cross-functional teams to improve processes.

Skills

Communication

Teamwork

Integrity

Confidentiality

Education

BS/BA or higher in science or technology

Job 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 with the patient at the center of our efforts. Our vision for Patient Centricity supports the development of innovative health solutions through understanding the patient experience. We believe all staff play a role in creating a patient-centric culture, integrating patient awareness into our daily practices. We have developed groundbreaking medicines in immunology, oncology, and urology, extending and saving lives, enabling transplantation, and improving quality of life for those with overlooked needs. Our approach focuses on translating science into treatments that directly impact patients' lives.

The Opportunity: As a Pharmacovigilance System Process Governance Professional at Astellas Pharma, you will ensure operational excellence in our Pharmacovigilance (PV) systems and global business operations. Your responsibilities include developing, maintaining, and improving PV IT systems, ensuring regulatory compliance, and enhancing process quality and efficiency. Your work will directly impact patient safety and therapy effectiveness.

Hybrid Working: We support a flexible work environment allowing you to balance home and office work. You will be part of an inclusive team developing innovative therapies for patients.

Key Activities:

1. Translate business requirements into system configurations to optimize operations.
2. Ensure safety database configurations comply with regulations and align with corporate strategies.
3. Oversee development of Computer System Validation documentation for PV IT systems.
4. Maintain validated status of safety databases and manage reference data.
5. Collaborate with cross-functional teams to meet regulatory requirements and improve processes.

Essential Knowledge & Experience:

• Extensive experience with PV-related IT systems and processes.
• Strong understanding of Case Management and compliance.
• Experience in the pharmaceutical industry, especially in PV processes or operations.
• Excellent communication and teamwork skills.
• High integrity and confidentiality.

Preferred Experience:

• Advanced degree in science or technology preferred.
• Experience managing IT systems and leading teams.
• Knowledge of Lean Six Sigma methodologies.

Education: BS/BA or higher in science or technology, or equivalent.

Additional Information:

• Full-time, permanent role.
• Based in the UK (Addlestone).
• Hybrid working model with at least 1 day per quarter in the UK office; flexibility may vary.

What We Offer:

• Challenging, diverse job in an international setting.
• Opportunities for development and growth.
• Inspiring work environment.

We are an equal opportunity employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.