Head of QPPV Office and PV Intelligence

vor 4 Wochen

Marburg, Deutschland CSL Behring Vollzeit

For our GSPV department, we are looking for a

Head of QPPV Office and PV Intelligence (m/f/x)

R-233736

Fulltime / permanent / non-tariff

The Opportunity

As Head of QPPV Office and PV Intelligence you will be responsible for the direction and management of the QPPV office team and the PV Intelligence function to ensure accurate descriptions are in place of CSL’s Pharmacovigilance system (the EU-Pharmacovigilance System Master File (PSMF)) and at national levels in compliance with applicable legislative requirements. In addition, the role oversees applicable PV regulations globally, leads the impact assessment of new/revised PV legislation on existing safety processes and is responsible for end-to-end oversight of such changes to the QPPV to support compliance of the GSPV function at a global level

The Role

  • Your main responsibility in this role will be to maintain and further develop the EU-PSMF as required in EU legislation as well as the UK PSMF as required in the UK legislation
  • You will oversee content of local PSMFs/Pharmacovigilance Sub-System Files (PSSFs) and ensure alignment with the EU-PSMF
  • Another focus for you will be to ensure compliance of CSL’s PV system with changes in the global regulatory environment by leading an end-to-end process for legislative changes related to PV including impact assessments and functional implementation of process changes where required
  • You will lead and develop a team of Pharmacovigilance professionals in line with departmental and company objectives and will act as SME during Health Authority inspections and support inspection readiness

Your Skills and Experience

  • Master’s degree in sciences (e.g., Medicine, Pharmacy, etc.)
  • 10+ years Pharmacovigilance experience in multinational pharmaceutical industry
  • SME of PSMF/local PSMF/PSSF and applicable legislation/guidelines
  • Broad understanding of the global PV system, its quality system, and the dependencies of PV activities across the company
  • Expert knowledge of international standards and regulatory requirements/ regulations and processes related to pharmacovigilance including GCP related Pharmacovigilance
  • Experience in project-management, CAPA and SOP development
  • Experience in people management

What we offer

  • Innovative work-environment at our R&D campus
  • CSL-subsidized company bike leasing
  • Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
  • Access to Gym facility on campus
  • 2 Wellness days per year (additional paid time off)
  • Family services such as psychological support, legal advisory, family care services and more for you and your direct family

For more information, please check out our global benefits below.

We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring

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