Associate Director, Pv Vaccine Expert
vor 13 Stunden
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us as an **Associate Director, PV Vaccine Expert - EUCAN** for our Vaccines Business Unit, based in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.**
**OBJECTIVE**:
- Responsible for supporting and ensuring that, with regard to vaccine product R&D and commercialization, Regional and Local Operating Company (LOC) pharmacovigilance (PV) systems and processes comply with regulatory, procedural, and contractual requirements across the appointed region.
- Works in close collaboration with Global Patient Safety Evaluation (GPSE), Global Vaccines Safety Evaluation (GVSE)/Vaccines Business Unit (VBU), and Regional Franchise Heads to serve as a liaison in the assigned territory and support vaccine launch strategies at the local and regional level.
- Manages the relationship with LOC PV personnel to best support the PV function and provides PV functional expertise and support to LOCs.
- Collaborates and liaises with GPSE (and GVSE) functions to ensure appropriate systems/processes are in place to support PV locally, regionally, and globally.
- In partnership with other GPSE (and GVSE) functions, leads, facilitates, and executes local, regional, and/or global strategies, as appropriate.
**ACCOUNTABILITIES**:
**PVAR Vaccine Lead, EUCAN (50-60%)**:
- Maintains appropriate stakeholder network within VBU, Commercial BU, LOC, and R&D to facilitate implementation of GPSE strategy and support vaccine launch and brand strategies, whilst prioritizing patient safety.
- In regards to vaccine products, acts as the PV Subject Matter Expert (SME) for the local PV teams.
- Undertakes analysis of vaccine PV-related regulatory change impacts to local, regional, and global procedures and/or Takeda policies in collaboration with Regional Affiliate Liaison, PVAR Regional Lead, GPSE process team, and LOC-based PV.
- Oversees and maintains the PVAR vaccine training strategy, working with GPSE/GVSE training groups, PVAR Center of Excellence (CoE), and VBU Medical Affairs, as applicable, to develop the pharmacovigilance capabilities across the region.
- Interfaces with the EU-Qualified Person for Pharmacovigilance (EU-QPPV) Office and/or Local QPPV (L-QPPV) for vaccine products, as required.
- Collaborates with LOC PV teams to support the implementation of any local risk minimization activities in the country/region.
- Supports with Market Research/Patient Support Programs and post-marketing studies at the local/regional level for vaccines, in compliance with applicable PV regulations, and in collaboration with applicable GPSE and VBU functions.
- Collaborates with Regional Vendor Oversight Lead on supplier/vendor oversight of vaccine post-marketing PV activities, including engaging/notifying EU-QPPV and/or L-QPPV/Patient Safety Lead (PSL) for input as needed.
- Interfaces with Commercial, GPSE, and VBU teams to facilitate smooth business partners relations/alliance management to successfully address any PVA activities.
- Works with GVSE/VBU to support PV LOC audit/inspection readiness activities, including preparation, onsite audit support, and post-audit activities (e.g. responses to inspection findings, root cause investigation, facilitating assignment of issues, and CAPA plan) in close collaboration with PVAR CoE, PV Medical Quality (PVMQ), and local PV teams.
- Works with the Access to Medicines (AtM) office for vaccine products in access countries, as required.
**PVAR Liaison activities (40-50%)**:
- Maintains appropriate stakeholder network within EUCAN and GEM/China business units, LOCs, and R&D to facilitate implementation of GPSE strategy.
- SME in the assigned region as it relates to regulatory requirements, resourcing, compliance, and other factors.
- Works with EUCAN/GEM/China Area Leads to connect LOC PV to GPSE.
- Works with PVAR Head of CoE and EUCAN/GEM/China Regional Heads to implement global, regional, and local PV strategies at the LOCs.
- Supports with impact analysis of PV-related regulatory changes, changes to local, regional and global procedures, and Takeda policies on local, regional, or global PV systems.
- Contributes to and manages assessment of LOC PV training needs and facilitates support for LOC PV training with active involvement/resource allocation, as needed.
- Responsible for execution of EU-QPPV requirements supporting oversight of PV systems and processes in Area LOCs.
- Maintains Descriptions of Pharmacovigilance Responsibilities (DPRs), if applicable, with LOC PSLs to provide official record of GPSE and LOC delegation of responsibilities.
- Works with Area Leads and LOC PSLs in support of LOC PV audits/inspections, including follow-up and CAPA management.
- Ensures close collaboration with QA and compliance disciplines, globally, regionally and locally, to best support LOC needs.
- Supports and advises the Area Leads and PSLs on the deve
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