Pharmacovigilance Quality Professional - #148614

Description

Pharmacovigilance Quality 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 Quality Professional at Astellas Pharma, you will play a crucial role in ensuring the excellence of our global Pharmacovigilance (PV) Quality Management System. You will be responsible for overseeing the quality of Individual Case Safety Reports (ICSRs) and ensuring compliance with worldwide pharmacovigilance regulations. Your contributions will directly impact patient safety and the effectiveness of our innovative therapies. Join us in our mission to change tomorrow by improving lives through cutting-edge healthcare solutions.

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 Responsibilities

• Establish and implement tools and processes to monitor ICSR quality metrics for the pharmacovigilance department and vendors.
• Ensure continuous monitoring of quality metrics, collaborating closely with internal and external stakeholders.
• Monitor compliance with inspection/audit response commitments and effectiveness checks.
• Provide feedback on outsourced PV case processing performance to facilitate process improvement opportunities.
• Lead meetings with vendors and internal stakeholders to review key metrics as defined in Vendor Relationship Management.
  
  

Essential Knowledge & Experience

• Previous and extensive experience in the pharmaceutical, biotechnology, or related industry.
• Significant experience in Pharmacovigilance, Regulatory Affairs, or Quality Assurance, including establishing standards and metrics in support of quality systems.
• Strong analytical skills with a focus on quality metrics and compliance.
• Excellent communication skills, fostering open dialogue and collaboration.
• Proven ability to take ownership and drive results in a fast-paced environment.
  
  

Preferred Experience

• Direct pharmacovigilance experience in a Quality or Compliance role.
• Advanced Excel skills, including the development and usage of formulas and macros.
• Experience working in a Pharmacovigilance Safety Database.
  
  

Education

• Bachelor’s Degree or equivalent.
  
  

Additional Information

• Type of role is full-time, permanent.
• Location is in the UK office (Addlestone).
• This position follows our hybrid working model. The role requires a blend of home and a minimum of 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.
  
  

What We Offer

• A challenging and diversified job in an international setting.
• Opportunity and support for 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.