Pharmacovigilance Operations Associate

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 the safety documents/aggregate report writing landscape, 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.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

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 [click to reveal email address] [email protected] . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

Requisition ID: 90407

Recruiter: Laure Urbain

Hiring Manager: Fiona Hurrell

Talent Partner: Mihaela Pascaru

Job Level: MM II

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