Pharmacovigilance Senior Specialist

Location: Roma 00144, Lazio, Italy 
Contract type: Permanent 
Job ID: 2959 

Are you passionate about patient safety and pharmacovigilance? Do you thrive in a dynamic, global environment where your expertise can make a real difference? LEO Pharma is looking for a dedicated Pharmacovigilance Senior Specialist to join our Global Safety & Regulatory Affairs team. If you are ready to take on a pivotal role in ensuring the safety and well-being of patients worldwide, we want to hear from you!

Shape the LEO Pharma of tomorrow

At LEO Pharma, we share a “challenge accepted” mindset, we look for people who thrive in uncharted territory, capable of handling versatile roles and willing to shape the LEO Pharma of tomorrow, with the aim to keep owning the space for underserved dermatological diseases and leaving a valuable legacy behind.

Your role

As a Pharmacovigilance Senior Specialist at LEO Pharma, you will play a crucial role in maintaining and enhancing our pharmacovigilance (PV) practices to ensure compliance with international and national regulations. Your responsibilities will include:

• Follow the strategic direction for Global Safety & Regulatory Affairs including the establishment and maintenance of locally standardized practices to ensure compliance with international and national regulations
• Acting as the primary PV interface with local health authorities.
• Managing PV deliverables and performance in Italy effectively.
• Processing safety information from spontaneous or solicited cases.
• Manage PV arrangements for Patient Support Programmes, Market Research and Soccial Media
• Ensuring reconciliation with all sources of PV cases and regulatory reporting of cases from interventional clinical trials, including Development Safety Update Reports (DSUR).
• Conducting regulatory surveillance of PV and maintaining necessary local records.
• Bridging local and global PV processes by communicating changes and transformations.
• Identifying and implementing improvements for PV processes and procedures.
• Providing PV training to partners and LEO Pharma employees.
• Supporting audits and inspections.
• Supporting the EU Qualified Person for Pharmacovigilance (QPPV) as needed.
• Updating the Global PSMF and ensuring a continuity plan is in place.
• Provide support to the Global Safety functions (Global Safety Operations, Global Safety Surveilance, QPPV Office) with assigned activities as needed.

Your qualifications

To succeed in this role, we imagine that you have the following qualifications:

• A Bachelor’s or Academic degree in life sciences, with a minimum of 5 years' experience in pharmacovigilance (post-marketing and clinical trials)
• Solid knowledge of local and EU PV regulations
• Fluent English skills, both oral and written
• Strong technical skills and the ability to manage complex PV processes
• A patient-centric approach, with a commitment to keeping patients at the heart of what we do

As a person, you have a proactive mindset, always looking to innovate and improve, and a results-driven attitude, with a focus on executing and delivering high-quality outcomes.

Your new team

You will be part of the Safety and Regulatory Affairs Italy, France and Iberia (IFI) cluster acting as the Safety Contact Person for Italy, reporting to the IFI PV Manager. Our collaborative environment promotes innovation, learning, and professional growth. You will work closely with internal stakeholders from Regulatory Affairs, Medical Affairs, Medical Information, Quality, Legal, and Commercial teams. Together, we strive to ensure the highest standards of patient safety and regulatory compliance

Your 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.

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.