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
1. Support the maintenance of the safety documents/aggregate report writing landscape, including calendar maintenance and regulatory requirements awareness.
2. Support the maintenance of the signal detection landscape, including signal management tracker maintenance and regulatory requirements awareness.
3. 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.
4. 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:
5. Bachelor's degree in a related field (Master's preferred).
6. Experience in safety documents/aggregate report management and writing and ideally knowledge of signal detection methodologies.
7. Knowledge of global GCP and GPvP regulations.
8. Strong interest in safety operations and their supporting IT systems.
9. Strong communication skills with the ability to work in an agile nature across various project teams and stakeholders.
10. Enthusiasm to learn and grow taking autonomy for your appropriate projects.
11. 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 .
RANDATUCB
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!