- 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.
- 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.
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Principal Clinical Safety Advisor for Pharmacovigilance - Ballerup, Danmark - LEO Pharma
Beskrivelse
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 Role
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:
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.
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:
Shape the LEO Pharma of tomorrow
At LEO Pharma, our mission transcends the conventional. We're on an ambitious path to become the leaders in medical dermatology worldwide.
we share a "challenge accepted" mindset and are guided by our winning behaviors of simplification, collaboration, and accountability, to achieve our goals.
Contact and Application
We will be processing applications on a continuous basis, so apply via the online portal as soon as possible.
We hope to hear from you
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.
For certain positions, LEO Pharma might complete a background check conducted by a third party.
Join us on our journey Beyond the Skin. Apply today