Pharmacovigilance Operations Associate

UCB S.A.; Slough; On-site; GBP 30,000 - 45,000; Full time

Job summary

UCB S.A. is seeking a Pharmacovigilance Operations Associate to enhance patient safety through effective management of safety documents and compliance. This role involves collaboration with cross-functional teams to ensure regulatory adherence and quality oversight, making it integral to UCB's mission to improve patient outcomes in neurology and immunology.

Qualifications

• Experience in safety documents management and writing.
• Strong interest in supporting IT systems.

Responsibilities

• Manage the global aggregate report calendar.
• Support innovation in safety report processes.
• Contribute to compliance and regulatory readiness.

Skills

Communication

Teamwork

Knowledge of GCP and GPvP regulations

Interest in safety operations

Education

Bachelor's degree in a related field

Master's preferred

Job description

Make your mark for patients

We are looking for a Pharmacovigilance Operations Associate who has strong communication skills and is a great team player to join us in our Patient Benefit Risk and Medical Safety team, based in one of our UCB offices in Belgium (Braine l’Alleud or Anderlecht), UK (Slough) or US (RTP).

About the role
This member of Pharmacovigilance Operations Excellence supports the development and implementation of the framework and infrastructure for UCB’s signal detection, benefit-risk, risk management and safety documents/aggregate report writing activities within the Patient Benefit Risk and Medical Safety team. You will be responsible for overseeing and managing various activities to ensure efficiency, compliance, and quality within the organization such as maintaining procedures and templates, completing regulatory intelligence, supporting the maintenance of the safety documents/aggregate report calendar, supporting the maintenance of the signal management tracker and ensuring quality oversight to support audit and inspection readiness

Who you’ll work with
You will be part of the Patient Benefit Risk and Medical Safety team, collaborating with cross-functional teams throughout the company and working closely with the product facing Benefit Risk and Medical Safety teams. You will work beside the Head of Signal Detection and Benefit Risk Evaluation Unit and will undertake regular communication with the Benefit Risk and Medical Safety Leadership Team to ensure projects are delivered in line with the department’s objectives and goals.

What you’ll do

• Support the maintenance of thesafety documents/aggregate report writinglandscape, including scheduling and management of the global aggregate report calendar and the maintanence of the aggregate report templates in line with regulatory feedback and guidance changes
• Support the maintenance of the signal detection landscape, including signal management tracker maintenance and regulatory requirements awareness.
• Support innovation and continuous improvement of safety documents/aggregate report writing processes and signal detection and benefit-risk methodologies within the Benefit Risk and Medical Safety team infrastructure.
• review of authored aggregate reports for quality and adherence to company standards
• Contribute to Benefit Risk and Medical Safety readiness for inspections and compliance with global regulations.

Interested? For this role, we’re looking for the following education, experience, and skills:

• Bachelor's degree in a related field (Master's preferred).
• Experience in safety documents/aggregate report management and writing and ideally knowledge of signal detection methodologies.
• Knowledge of global GCP and GPvP regulations.
• Strong interest in safety operations and their supporting IT systems.
• Strong communication skills with the ability to work in an agile nature across various project teams and stakeholders.
• Enthusiasm to learn and grow taking autonomy for your appropriate projects.
• Experience in biopharmaceutical clinical development and pharmacovigilance is a plus.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.