PV Process Expert

Application deadline:  
Location: Ballerup 2750, , Denmark 
Contract type: Permanent 
Job ID: 3829 

Are you driven by the opportunity to shape and optimize pharmacovigilance (PV) processes? LEO Pharma is looking for a experienced and impactful PV Process Expert to take on a strategic and influential role within our Global Safety Operations team. This is your opportunity to work with a global team, ensuring compliance, driving innovation, and contributing to the safety of our products worldwide. If you’re a strategic thinker with deep pharmacovigilance expertise and a passion for driving global safety standards, we encourage you to apply!

Join us in creating a future legacy in medical dermatology.

At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicine.

Your Role: 

As a PV Process Expert, you will play a pivotal role in assessing, developing, and maintaining high-quality, compliant, and efficient solutions that align with LEO Pharma’s global safety strategy and business objectives. You'll lead and manage projects, mentor colleagues, and ensure all PV processes meet the highest standards of operational and regulatory compliance.

Your key areas of responsibility will include:

•    Challenging and enhancing existing processes while developing high-level procedures and principles.
•    Leading implementation projects and creating QMS documents, tools, and templates.
•    Collaborating with clinical teams to align PV processes with study protocols and data flows, applying clinical insights to improve signal detection, case processing, and safety reporting.
•    Ensuring compliance with safety and pharmacovigilance regulations, standards, and guidelines.
•    Aligning internal QMS documents with legislative requirements and supporting Due Diligence processes in collaboration with Global Business Development.
•    Representing Global Safety Operations (GSO) during audits and inspections, managing follow-ups and responses.
•    Working cross-functionally with Legal, QA, and external partners to proactively resolve findings and ensure seamless compliance.
•    Partnering with affiliates, sourcing partners, and multiple internal departments to support cross-functional projects and negotiate process implementations.
•    Acting as a Subject Matter Expert (SME) for safety systems, defining user requirements, and ensuring timely delivery of project milestones.

Your Qualifications

To succeed in this role, you should bring:

•    A minimum of 5 years of extensive experience in pharmacovigilance is essential, ideally within an international, project-oriented organization. You should have a proven record of working across complex global structures and driving process improvements.
•    Strong medical/scientific knowledge and a good understanding of clinical trials within pharmacovigilance.
•    In-depth knowledge of global regulatory requirements (EMA/FDA/ICH).
•    Proven ability to analyze and interpret data with strong medical and scientific writing skills.
•    Proficiency in verbal and written English and strong computer literacy (Microsoft Office, safety databases).
•    Strategic thinking and influencing capabilities, with a collaborative and results-driven mindset.
•    Courage to address complex issues, adaptability to learn quickly, and a focus on achieving results under tough circumstances.

Contact and Application

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Please refrain from adding a photo to your CV.

Your new Team

At LEO Pharma, we aim to improve the lives of people with skin diseases. As a PV Process Expert, you’ll have a direct impact on this mission, shaping the safety of our products and driving advancements in pharmacovigilance processes. Join us in a role where your expertise will be valued, your insights will shape strategies, and your contributions will make a difference across the globe.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

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