Senior PV Compliance Specialist

Titlul postului:

Senior PV Compliance Specialist

Companie

Leo Pharma

Descrierea postului

Location: Ballerup 2750, Denmark, Denmark
Contract type: Permanent
Job ID: 2927Are you an experienced pharmaceutical professional with a strong background in pharmacovigilance and a passion for ensuring patient safety? Do you thrive in a dynamic environment where your expertise can drive collaboration and support global safety initiatives? At LEO Pharma, we are committed to helping people achieve healthy skin through innovative treatments. We invite you to join our QPPV Office team in Denmark, where you will play a crucial role in supporting the global pharmacovigilance system.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. If you’re ready to make a difference, this role is your gateway to a world of opportunities!Your RoleYour key responsibilities will include:

• Proactively manage and coordinate the Global Compliance System by compiling and managing data and documents for Global Safety Compliance including the PSMF.
• Plan, manage and coordinate PSMF updates and maintenance in accordance with LEO procedures.
• Manage and build day-to-day relationships with internal LEO Pharma stakeholders.
• Develop, maintain and improve PSMF quality control procedures.
• Act as Global Safety SME for PSMF topics and documentation, and for documenting deviations and CAPAs.
• Manage delegated QPPV Office tasks and lead or contribute to LEO Pharma projects.
• Manage, coordinate and participate in global and local PV audit/inspections.
• Support and maintain a PV CAPA process for audit/inspections including CAPA management.
• Prepare and compile Monthly Global Safety Quality Report to QPPV and Global Safety Management for oversight of metrics and KPIs
• Develop and maintain Monthly Global Safety Quality Report concept.
• Generate and compile Global Safety data for Quality Management Report (QMR).
• Compile data for PV KPI analysis and compliance performance.
• Present Monthly Compliance Reports to Global Safety management.
• Assess and report on Global PV compliance status and risks.
• Ensure compliance with data protection laws like GDPR.
• Conduct privacy impact assessments and mitigate risks.
• Address data breaches or non-compliance issues promptly within Global Safety.
• Maintain and update related Global Safety QMS documents.
• Drive tasks of high complexity in internal or cross-functional projects, as delegated.
• Develop or improve procedures within area of responsibility.

Your QualificationsTo excel in this role, you will need:

• Pharmacist, or other equivalent Master’s qualification, preferably in a natural science discipline.
• Extensive experience within the pharmaceutical industry – min 5-7 years.
• Solid pharmacovigilance knowledge preferably from different areas.
• Solid experience with PV Systems and QPPV compliance support.
• Strong data literacy and quality mindset with the capabilities to analyze and trend on data.
• Excellent communication skills and ability to build strong relationships.
• Structured and detail oriented.
• Strong sense of processes and procedures.
• Proficient in verbal and written English.
• Good IT skills and experienced user of common Microsoft Office programs, Veeva Vault and Power BI.

Your New TeamWelcome to the QPPV Office at LEO Pharma! Here, you will join a dedicated group of professionals committed to ensuring our pharmacovigilance processes are efficient, compliant, and effective. Reporting to the Director, QPPV, Head of QPPV Office, you will collaborate closely with various internal stakeholders and external partners. Our team values open communication, strong collaboration, and a shared commitment to excellence, continually pushing the boundaries to deliver compliant pharmacovigilance solutions while having fun and fostering a great work environment.Contact and ApplicationReady to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.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 skinJoin 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!

Salariu așteptat

Locație

Ballerup, Hovedstaden

Data jobului

Thu, 01 May 2025 02:33:35 GMT

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