Zurich, Switzerland
Apply NowEmail MeTakeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
Back to Job Navigation (Overview)
What makes a successful member of our team?
Putting the patient
at the center
Building trust
with society
Reinforcing our
reputation
Developing the
business
Back to Job Navigation (Success)
To keep delivering new value to patients, we provide growth opportunities for every employee according to their abilities and passions, and together are building a stronger organization.
Procurement Lead, Northern Europe
“Takeda is a unique place to work as there is no ‘every-day routine’ around here – it’s very a dynamic environment where change of plans and adjustments of approach are the constants... This allows for interesting cross-function collaboration and – if you’re up for it - a high degree of influence on your daily job and workplace.”Regional Head, Europe, Vaccines
“Takeda is a great place to work as the company invests in the continuous development of its employees offering training, coaching, mentoring and open exchanges between all levels of the organization. Also, it is fulfilling to know that, within the Vaccine Business Unit, we are developing and delivering innovative vaccines impacting the lives of millions of people around the world.”Back to Job Navigation (Life at Takeda)
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
Back to Job Navigation (Rewards)
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
This role is responsible for supporting and ensuring that, with regard to vaccine products R&D and Commercialization, Regional or Local Operating Companies (LOC)Pharmacovigilance (PV)system and processes comply with regulatory, procedural or contractual requirements across the appointed region.
Additionally, this role drives implementation of relevant vaccine-related LOC PV regional process and compliance initiatives, including audit/inspection activities and readiness, and business continuity and continuous improvement, where applicable.
The main activities are the following :
▪Work in close collaboration between GPSE and the Vaccines Business Unit (VBU)/Global Vaccine Safety and Evaluation (GVSE), ensuring alignment with the global GPSE Compliance, EU-QPPV/LQPPV, and relevant R&D LOC PV Quality strategies.
▪Identify, plan and execute process harmonization initiatives that will further process efficiencies and harmonization in collaboration with LOC-based PV roles and broader GPSE community focusing on vaccine products R&D and Commercialization
▪Responsible for vaccine products-related Compliance in the appropriate region and ensure close collaboration with compliance disciplines, globally, regionally and locally to best support LOC needs (e.g. disseminate global metrics to local PV)
ACCOUNTABILITIES:
•Pharmacovigilance agreements (PVAs)/Safety Data Exchange Agreements (SDEAs)
Develop and manage PVAs with Licensing Partners, on behalf of VBU and with VBU’s input and support and in collaboration with GPSE and Commercial, where relevant
Manage PVA vendor and interfaces with Commercial teams and GPSE to facilitate smooth business partners relations/Alliance management to successfully address any PVA activities
•To be the PV Subject Matter Expert (SME), representing the VBU of the assigned territory towards internal as well as external stakeholders
•Ensure oversight of PV system activities related to vaccine related products in close collaboration with the LOCs of the assigned region
•Maintains appropriate stakeholders network with VBU, Commercial BU, LOC and R&D to facilitate implementation of GPSE strategy and serve as a liaison in their assigned territory
•Interface with the EU-Qualified Person for Pharmacovigilance (EU-QPPV)/ Local QPPV(L-QPPV) and PSMF expert to identify, provide and update requirements for L-QPPV and Pharmacovigilance System Master File (PSMF)
Provide EU-QPPV office/ L-QPPV support for vaccine products (as needed)
Coordinate collaboration, review and approval of PASS by the EU QPPV
Provide local support for supplier/vendor oversight [Post-marketing] including engaging/notifying EU-or L-QPPV for input, as necessary
Manage and maintain the relevant sections of the PSMF for the Product(s) as required
Assist/coordinate the process for approval of EU, global and local RMPs, medical safety activities, Company Core Data sheet and EU SmPC, as needed
Post Approval Safety Studies (PASS)
Supports planning, execution and management of any local Post Authorization Safety Studies (PASS) required by the Regulatory Authority(ies) for the Product(s) in collaboration with the applicable GPSE functions including the EU QPPV
• Literature Review
Ensure that applicable local monitoring of literature is performed
Literature review, if required, prior to market approval will be performed
• PV Regulatory Intelligence
Undertake analysis of vaccine products, PV-related regulatory change impact to local, regional and global procedures and/or Takeda policies in collaboration with the Regional Affiliate Liaison, GPSE process team and LOC based PV
Responsible for tracking and reviewing of expedited and periodic reporting requirements for vaccine products in the applicable territories
Review includes, but is not limited to, regulations affecting:
▪ Post-marketed vaccine products’ expedited and periodic reporting requirements to the applicable Regulatory Authorities
▪ Any changes to vaccine products’ reporting requirements in GSDB (e.g. destination change, E2B validation rules etc.)
Notify GPSE when any new changes, or requirements are identified
• Collaborate with Patient Safety Leads (PSLs) to support the VBU in implementing any local Risk Minimization activities in their country/region.
• Quality and Compliance
Work with VBU/GVSE 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 GPSE Compliance, PV Affiliate Liaison and LOC Quality and QPPV teams
▪ Where relevant, manage Quality Events (QEs)/Corrective and Preventive Actions (CAPAs) owned by each respective function, in conjunction with QA
▪ Inform other departments and collaborate as requested with each other, as applicable, of any inspections by Regulatory Authorities relevant to Pharmacovigilance activities and systems
Support vaccine-specific inspections/audits regarding GPSE processes and requests
• Standards and Training
Ensure alignment between VBU-PV and GPSE Compliance, Standard & Training processes where needed and ensures that vaccine products R&D and Commercialization practices are reflected in local PV processes, responsibilities, systems, standards and training within the LOC/region and in line with Global SOPs and local regulations
Provide training for DSOs/PSLs on vaccine-specific process updates/changes
Provide training for DSOs/PSLs on GPSE process updates/changes that impact vaccines
• Vendor Oversight
identify, plan and execute regional and local vendor oversight harmonization initiatives that drive further alignment, harmonization, efficiency and inspection readiness in collaboration with LOC PV, Regional vendor oversight colleagues and broader GPSE community
EDUCATION, EXPERIENCE AND SKILLS
Excellent written/verbal communication skills and fluent in written and spoken English
▪ Significant scientific and/or health professional degree; bachelor’s 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 or experience to vaccine research and development and Commercial activities as an advantage
▪ Significant experience in PV-related environments, preferably at local, regional and/or global levels
▪ Advanced experience of working cross-functionally. Experience working with or in pharma (Commercial) is preferred
▪ 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
▪ 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
Back to Job Navigation (Responsibilities)
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
This role is responsible for supporting and ensuring that, with regard to vaccine products R&D and Commercialization, Regional or Local Operating Companies (LOC)Pharmacovigilance (PV)system and processes comply with regulatory, procedural or contractual requirements across the appointed region.
Additionally, this role drives implementation of relevant vaccine-related LOC PV regional process and compliance initiatives, including audit/inspection activities and readiness, and business continuity and continuous improvement, where applicable.
The main activities are the following :
▪Work in close collaboration between GPSE and the Vaccines Business Unit (VBU)/Global Vaccine Safety and Evaluation (GVSE), ensuring alignment with the global GPSE Compliance, EU-QPPV/LQPPV, and relevant R&D LOC PV Quality strategies.
▪Identify, plan and execute process harmonization initiatives that will further process efficiencies and harmonization in collaboration with LOC-based PV roles and broader GPSE community focusing on vaccine products R&D and Commercialization
▪Responsible for vaccine products-related Compliance in the appropriate region and ensure close collaboration with compliance disciplines, globally, regionally and locally to best support LOC needs (e.g. disseminate global metrics to local PV)
ACCOUNTABILITIES:
•Pharmacovigilance agreements (PVAs)/Safety Data Exchange Agreements (SDEAs)
Develop and manage PVAs with Licensing Partners, on behalf of VBU and with VBU’s input and support and in collaboration with GPSE and Commercial, where relevant
Manage PVA vendor and interfaces with Commercial teams and GPSE to facilitate smooth business partners relations/Alliance management to successfully address any PVA activities
•To be the PV Subject Matter Expert (SME), representing the VBU of the assigned territory towards internal as well as external stakeholders
•Ensure oversight of PV system activities related to vaccine related products in close collaboration with the LOCs of the assigned region
•Maintains appropriate stakeholders network with VBU, Commercial BU, LOC and R&D to facilitate implementation of GPSE strategy and serve as a liaison in their assigned territory
•Interface with the EU-Qualified Person for Pharmacovigilance (EU-QPPV)/ Local QPPV(L-QPPV) and PSMF expert to identify, provide and update requirements for L-QPPV and Pharmacovigilance System Master File (PSMF)
Provide EU-QPPV office/ L-QPPV support for vaccine products (as needed)
Coordinate collaboration, review and approval of PASS by the EU QPPV
Provide local support for supplier/vendor oversight [Post-marketing] including engaging/notifying EU-or L-QPPV for input, as necessary
Manage and maintain the relevant sections of the PSMF for the Product(s) as required
Assist/coordinate the process for approval of EU, global and local RMPs, medical safety activities, Company Core Data sheet and EU SmPC, as needed
Post Approval Safety Studies (PASS)
Supports planning, execution and management of any local Post Authorization Safety Studies (PASS) required by the Regulatory Authority(ies) for the Product(s) in collaboration with the applicable GPSE functions including the EU QPPV
• Literature Review
Ensure that applicable local monitoring of literature is performed
Literature review, if required, prior to market approval will be performed
• PV Regulatory Intelligence
Undertake analysis of vaccine products, PV-related regulatory change impact to local, regional and global procedures and/or Takeda policies in collaboration with the Regional Affiliate Liaison, GPSE process team and LOC based PV
Responsible for tracking and reviewing of expedited and periodic reporting requirements for vaccine products in the applicable territories
Review includes, but is not limited to, regulations affecting:
▪ Post-marketed vaccine products’ expedited and periodic reporting requirements to the applicable Regulatory Authorities
▪ Any changes to vaccine products’ reporting requirements in GSDB (e.g. destination change, E2B validation rules etc.)
Notify GPSE when any new changes, or requirements are identified
• Collaborate with Patient Safety Leads (PSLs) to support the VBU in implementing any local Risk Minimization activities in their country/region.
• Quality and Compliance
Work with VBU/GVSE 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 GPSE Compliance, PV Affiliate Liaison and LOC Quality and QPPV teams
▪ Where relevant, manage Quality Events (QEs)/Corrective and Preventive Actions (CAPAs) owned by each respective function, in conjunction with QA
▪ Inform other departments and collaborate as requested with each other, as applicable, of any inspections by Regulatory Authorities relevant to Pharmacovigilance activities and systems
Support vaccine-specific inspections/audits regarding GPSE processes and requests
• Standards and Training
Ensure alignment between VBU-PV and GPSE Compliance, Standard & Training processes where needed and ensures that vaccine products R&D and Commercialization practices are reflected in local PV processes, responsibilities, systems, standards and training within the LOC/region and in line with Global SOPs and local regulations
Provide training for DSOs/PSLs on vaccine-specific process updates/changes
Provide training for DSOs/PSLs on GPSE process updates/changes that impact vaccines
• Vendor Oversight
identify, plan and execute regional and local vendor oversight harmonization initiatives that drive further alignment, harmonization, efficiency and inspection readiness in collaboration with LOC PV, Regional vendor oversight colleagues and broader GPSE community
EDUCATION, EXPERIENCE AND SKILLS
Excellent written/verbal communication skills and fluent in written and spoken English
▪ Significant scientific and/or health professional degree; bachelor’s 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 or experience to vaccine research and development and Commercial activities as an advantage
▪ Significant experience in PV-related environments, preferably at local, regional and/or global levels
▪ Advanced experience of working cross-functionally. Experience working with or in pharma (Commercial) is preferred
▪ 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
▪ 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
Back to Job Navigation (Responsibilities)