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.

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

WHAT YOU’LL DO

• Support the maintenance of the safety documents/aggregate report writing landscape, including calendar maintenance and regulatory requirements awareness.
• 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.
• 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.
  If you are interested to learn more about R&D within UCB, please find more information here R&D at UCB.