Associate Director, PV Vaccine Expert - EUCAN

Associate Director, PV Vaccine Expert - EUCAN

Zurich, Switzerland

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Associate Director, PV Vaccine Expert - EUCAN

Job ID
R0078232Date posted Jan.. 13, 2023Location Zurich, SwitzerlandApply

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?Join us asan Associate Director, PV Vaccine Expert - EUCAN for our Vaccines Business Unit, basedin 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 development/maintenance of PV systems in LOCs and facilitates, as appropriate, local PV SOPs.
• Works with PVAR Head of CoE and EUCAN/GEM/China Regional Heads, Area Leads, and other stakeholders to facilitate best practice sharing and ongoing process improvement and identification of process efficiencies.
• Ensures all contact information and any changes of LOC PV personnel are

maintained for GPV communications.

EDUCATION, EXPERIENCE AND SKILLS:

• Significant scientific and/or health professional degree; bachelor's degree required in life sciences, pharmacy, nursing, or medical. Advanced degree preferred.
• Minimum of 5 years' pharmaceutical or health care-related industry experience required, with significant exposure to or experience with vaccine research and development and Commercial activities as an advantage
• Significant experience in PV-related environments, preferably at local, regional and/or global levels
• Excellent knowledge of vaccine-specific PV regulations for the post marketing global environment and regional legislation in particular
• Familiarity, or preferably experience, with PV-related inspections and audit procedures
• Understanding of medical/scientific terminology
• Advanced experience of working cross-functionally
• Excellent written/verbal communication skills and fluent in written and spoken English
• Accuracy and attention to detail
• Flexible mindset
• High degree of cross-cultural awareness
• Self-motivated and accountable team member with collaborative approach
• Capable of prioritizing under pressure with well-developed organizational skills
• High standard of computer literacy

WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering Our People to Shine

Discover more at takedajobs.com

At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability. Our team is growing and for this we need bright minds with creativity and flexibility - what talent do you have?

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time Apply