Principal Clinical Safety Advisor for Pharmacovigilance & Safety

at  LEO PHARMA AS

Field of work: Clinical Development
Posting Date: 30 Apr 2024
Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 2096
Would you like to utilize your competencies within clinical trials broadly and influence projects? With us, you will have a strategic role and the opportunity to work with all parts of clinical development.
You will join Leo Pharma Global Safety Surveillance team. We are responsible for providing overall safety surveillance for assigned products on an on-going basis and are the subject matter experts for Pharmacovigilance activities. In collaboration with various departments, we ensure our products are safe for patients worldwide.
We are a department of 18 Clinical Safety Professionals, organized in two teams, and by joining our team you can expect to be part of a highly professional and supportive environment.

YOUR QUALIFICATIONS

We are looking for you, who can bring a collaborative and customer-oriented mind-set. Just as it will be key, that you can manage multiple projects and stakeholders. This requires you to think strategically, focus on aligning plans and communicates effectively. Another important aspect is to ensure compliance.

We imagine that you possess:

• A University degree in health or biological sciences, supplemented with several years in a project-oriented, international organization, preferably in pharmacovigilance.
• Experience in clinical/drug development processes.
• Solid knowledge in medical and scientific evaluation, specifically signal detection. and evaluation.
• Understanding of global regulatory requirements (EMA/FDA/ICH).
• Proficiency in data analysis and interpretation.

You will contribute directly to patient care and compliance on a global scale. In this role, you will be responsible for the safety profile of our products in clinical development and those new to market, ensuring they meet the highest standards of pharmacovigilance. You will therefore:

• Proactively manage and monitor the safety of assigned LEO Pharma products.
• Perform critical analysis and medical evaluation of emerging safety data and contribute to establishment of the product safety profile.
• Lead key functional initiatives to optimize processes and ensure regulatory compliance.
• Train and develop other professionals, establishing yourself as a PV subject matter expert.
• Communicate critical safety information internally and to health authorities.
• Prepare and review pivotal safety documentation and regulatory submissions.

This role entails for you to be a ‘go-to’ person that trains and develops other experienced professionals. Furthermore, you will be leading cross-departmental project groups, contributing to strategy development, and representing LEO Pharma at external meetings.
Your medical evaluations will play a crucial part in our commitment to patient safety and product excellence.