Head of administration Jobs in Dautphetal

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

What we offer