Pharmacovigilance Scientist

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading pharmaceutical company is seeking a Pharmacovigilance Scientist. This role involves managing safety surveillance and signal detection for products, developing safety strategies, and collaborating with internal teams. The ideal candidate will have extensive pharmacovigilance experience and strong regulatory knowledge. This is a permanent, full-time position with hybrid working options in the UK or Poland.

Qualifications

• Extensive experience in pharmacovigilance, signal detection, and risk management.
• Ability to work effectively in global, cross-functional teams.
• Strong knowledge of ICH/FDA regulations and drug safety guidelines.
• Proficiency in pharmacovigilance reporting systems and MS Office.
• Excellent communication skills in English.

Responsibilities

• Manage signal detection and safety evaluations for Astellas products.
• Develop and lead safety surveillance strategies.
• Lead safety report preparations, including PSUR, DSUR, and PADER.
• Build relationships with stakeholders.
• Mentor and train junior team members.

Skills

Extensive experience in pharmacovigilance

Ability to work effectively in global teams

Strong knowledge of ICH/FDA regulations

Proficiency in pharmacovigilance systems

Excellent communication skills in English

Education

Bachelor’s degree or equivalent

Tools

MS Office

Job description

Job Title: Pharmacovigilance Scientist

About Astellas: At Astellas, we are a progressive health partner committed to delivering value and outcomes where needed. We focus on innovative science, especially in areas with high patient need, such as rare or under-served diseases and life-threatening conditions. We work directly with patients, healthcare professionals, and regulatory bodies to ensure patient-centric solutions and access to new therapies. Our goal is to develop medicines that provide meaningful outcomes and support stakeholder communities in improving awareness, education, and standards of care.

The Opportunity: As a Pharmacovigilance Scientist, you will manage safety surveillance and signal detection efforts for Astellas products. You will develop safety strategies, collaborate with internal teams and vendors, and ensure timely safety reporting to health authorities.

Hybrid Working: We offer a flexible hybrid working model, allowing you to work from home or from the office, with a minimum of one day per week in our UK or Poland offices.

Key Activities:

1. Manage signal detection and safety evaluations for Astellas products.
2. Develop and lead safety surveillance strategies.
3. Lead safety report preparations, including PSUR, DSUR, and PADER.
4. Build relationships with stakeholders.
5. Mentor and train junior team members.

Essential Knowledge & Experience:

1. Extensive experience in pharmacovigilance, signal detection, and risk management.
2. Ability to work effectively in global, cross-functional teams.
3. Strong knowledge of ICH/FDA regulations and drug safety guidelines.
4. Proficiency in pharmacovigilance reporting systems and MS Office.
5. Excellent communication skills in English.

Education: Bachelor’s degree or equivalent.

Additional Information:

• This is a permanent, full-time position.
• Based in the United Kingdom or Poland.
• Requires a blend of home and office work, with flexibility based on business needs.

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