At a Glance
- Tasks: Support safety document management and signal detection processes in a collaborative team environment.
- Company: UCB is a global biopharmaceutical company focused on neurology and immunology, driven by patient needs.
- Benefits: Enjoy a supportive culture, opportunities for growth, and the chance to make a real impact.
- Why this job: Join a team that values innovation and collaboration while making a difference for patients worldwide.
- Qualifications: Bachelor's degree required; experience in safety documents and strong communication skills preferred.
- Other info: Diversity and inclusion are core values at UCB; we welcome applicants from all backgrounds.
The predicted salary is between 36000 - 60000 £ per year.
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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
#J-18808-Ljbffr
Pharmacovigilance Operations Associate employer: UCB S.A.
Contact Detail:
UCB S.A. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Pharmacovigilance Operations Associate
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to pharmacovigilance. Understanding GCP and GPvP regulations will not only boost your confidence but also demonstrate your commitment to compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmacovigilance field. Attend industry conferences or webinars, and connect with people on platforms like LinkedIn. This can provide you with insights into the role and may even lead to referrals.
✨Tip Number 3
Showcase your communication skills by preparing to discuss examples of how you've effectively collaborated with cross-functional teams. Highlighting your teamwork experience will resonate well with the collaborative culture at UCB.
✨Tip Number 4
Research UCB’s recent projects and initiatives in pharmacovigilance. Being knowledgeable about their work will allow you to ask informed questions during the interview, showing your genuine interest in the company and its mission.
We think you need these skills to ace Pharmacovigilance Operations Associate
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Pharmacovigilance Operations Associate position. Tailor your application to highlight how your skills and experiences align with the job description.
Highlight Relevant Experience: In your CV and cover letter, emphasise any experience you have in safety document management, aggregate report writing, or pharmacovigilance. Use specific examples to demonstrate your knowledge of signal detection methodologies and regulatory compliance.
Showcase Communication Skills: Since strong communication skills are essential for this role, provide examples in your application that showcase your ability to collaborate effectively with cross-functional teams. Mention any relevant projects where you successfully communicated complex information.
Express Enthusiasm for Learning: UCB values candidates who are eager to learn and grow. In your application, convey your enthusiasm for the field of pharmacovigilance and your willingness to take on new challenges. This can set you apart from other applicants.
How to prepare for a job interview at UCB S.A.
✨Know Your Regulations
Familiarise yourself with global GCP and GPvP regulations. Being able to discuss these during your interview will show that you understand the compliance landscape and are prepared to contribute to safety operations.
✨Showcase Your Communication Skills
As strong communication is key for this role, prepare examples of how you've effectively communicated in past projects. Highlight your ability to work collaboratively across teams, as this will resonate well with the interviewers.
✨Demonstrate Your Passion for Safety Operations
Express your enthusiasm for pharmacovigilance and safety operations. Share any relevant experiences or projects that showcase your interest and commitment to improving patient safety.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to manage multiple tasks. Think about how you would handle specific challenges related to signal detection and report writing, and be ready to discuss your thought process.