Regional Head, PSPV-Affiliate Management APAC, ME & CIS

Takeda Pharmaceutical; Zürich; On-site; CHF 213,000 - 292,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Regional Head of PSPV-Affiliate Management APAC, ME & CIS to lead pharmacovigilance across Intercontinental LOCs. You will align local PV activities with PSPV strategies and guide the AI and digital transformation journey within PV.

You will report to the PSPV-AM leadership and collaborate with Medical Affairs, Regulatory Affairs and Quality across multiple countries. The role requires global coordination, a strategic mindset, and strong leadership to

Qualifications

• Bachelor's or advanced degree required, healthcare/life sciences preferred.
• 12+ years in pharma with leadership and PV exposure.
• Meets local QPPV/PV contact requirements if applicable.
• Advanced PV knowledge with global/local regulations and planning.
• Strong leadership, matrix collaboration across regions.
• Experience leading transformation or digital/AI enablement.
• Experience with AI/digital PV solutions incl. data privacy and GxP.
• Experience with global/shared service or external partners.
• Strategic mindset translating global strategy to regional roadmap.
• International, cross-cultural, multi-country experience.
• Ability to analyse complex data and drive solutions.
• Excellent planning and time management, flexible under ambiguity.
• Excellent written/oral English; other languages beneficial.

Responsibilities

• Provide leadership to PSPV-AM and LOC PV staff in APAC, ME & CIS region.
• Set regional strategy aligned with leadership and PSPV"s broader plan.
• Ensure local, regional and global PV strategies meet regulatory requirements.
• Chair regional pharmacovigilance forum; define goals and KPIs.
• Coordinate SA/Compliance and QA across LOCs; manage CAPA.

Skills

PV leadership

Regulatory knowledge

Cross-country collaboration

AI/digital solutions

PV operations

GCM coordination

English communication

Education

Bachelor's or advanced degree

Job description

Job Description

At our heart we 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, sexual orientation, race, color, ethnic or social origin,or disability.

Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

About the role

• This is a regional role. The Regional Head, PSPV-Affiliate Management APAC, ME & CIS is responsible for overseeing all pharmacovigilance activities within the Intercontinental region, excluding Latin America, including the management, direct or functional, of all PSPV-AM staff in that region.
• Ensure local PV alignment with PSPV and regional alignment with Medical Affairs, Regulatory Affairs, Quality and Commercial, and provide leadership, vision and functional expertise to the PV Country Leads and local PV personnel in every Local Operating Company (LOC) within the regional scope.
• In addition to the regional remit, the role is accountable for the AI, digital solutions and transformation agenda across the entire PSPV-AM organisation, covering all regions and LOCs.
• The role is the accountable Global Capability Model (GCM) interface for PSPV-AM in India and holds a coordinating role for GCM transformation across PSPV-AM.

How you will contribute

• Provide leadership and oversight to all PSPV-AM and local personnel engaged in pharmacovigilance activities in the APAC, ME & CIS region , including the direct or functional management of all PSPV-AM staff in the region.
• Set and implement the strategy for the APAC, ME & CIS region in alignment with the PSPV-AM Leadership Team and the broader PSPV strategy and establish long-term plans and goals together with applicable local and global stakeholders, including the EU QPPV.
• Ensure the effective implementation of local, regional and global strategies across the Local Operating Countries (LOCs) in the region to maintain procedural and regulatory compliance.
• Chair the regional pharmacovigilance forum for the APAC, ME & CIS region and set the goals, priorities, key performance metrics and long-term plans within the region.
• Ensure regional strategies incorporate EU and local QPPV / PV contact person requirements, and work with the global and local qualified persons for pharmacovigilance in the region to ensure the accuracy of the pharmacovigilance system and of the Pharmacovigilance System Master File (PSMF).
• Foster a culture of inclusiveness and collaboration and establish strong matrix partnerships with colleagues, including Local/Regional Medical Directors, Country General Managers and colleagues supplying sources of safety information within both R&D and the Commercial organisation.
• Proactively collaborate with Medical Affairs, Regulatory Affairs and Quality to address the region's pharmacovigilance needs, ensuring cross-functional alignment and that LOCs maintain compliance with pharmacovigilance requirements.
• Collaborate with PSPV Compliance, Training and Alliance, as well as the Takeda Quality organisation, to ensure a high level of PV and training compliance at all LOCs in the region.
• Collaborate with Global PV Compliance, the EU QPPV and the Takeda Quality organisation to ensure oversight of all audit and inspection related activities and outputs applicable to the region, including follow-up and CAPA management.
• Develop strategies to align and simplify relevant SOPs, processes and tools within the region to meet the operational and training needs of the PV staff at the LOCs.
• Maintain proficiency in applicable local knowledge of key drug safety regulations, act upon developments in the PV landscape, and provide leadership for impact analyses of country- and region-specific regulatory changes on regional and global PV systems and vice versa.
• Ensure financial accountability and oversight of the PV operating budgets within the region, and address resourcing needs and strategies so that they meet Takeda and local, regional and global PV requirements, in alignment with the Head of PSPV Affiliate Management.
• Establish and oversee local and regional PV suppliers within the region, including scope, service levels, quality metrics and appropriate oversight measures.
• Promote clear communication between Global PV and the local PV staff within the region, act as an advocate for the local PV staff and their LOCs within the PSPV organisation, and ensure that PV and management issues escalated in each LOC are addressed.
• Influence internal and external stakeholders, both in R&D and the Commercial organisation, to build the reputation of pharmacovigilance and drive the promotion of patient safety within the region.
• Embrace the Takeda cultural mind-set of “Patient, Trust, Reputation and Business” in the workplace, undertaking personal accountability to live these values as we work within our one PSPV worldwide team and represent our PSPV function inside and outside of the company, as appropriate.

Digital solutions, AI and transformation and GCM interface

• Lead the AI and digital solutions agenda for affiliate pharmacovigilance across the entire PSPV-AM organisation, covering all regions and LOCs, in partnership with the Head of PSPV-AM, the Regional Heads, PSPV Business Excellence and Data, Digital & Technology.
• Define the PSPV-AM roadmap, priorities and success metrics for AI, digital and automation use cases, such as local data screening, translation, workflow automation and compliance analytics, and drive consistent adoption across regions.
• Ensure all AI and digital use cases are assessed, validated and documented in line with Takeda's PV quality system, GxP and data privacy requirements; accountable human oversight remains with the qualified PV personnel in each country.
• Act as the accountable GCM interface for PSPV-AM in India, covering scope of transitioned activities, service levels, quality metrics, escalation routes and clear role delineation so that local regulatory accountability is never at risk.
• Oversee India GCM readiness, training, knowledge transfer and delivery performance against agreed metrics, and represent PSPV-AM in the India GCM governance forums.
• Coordinate GCM transformation across the whole PSPV-AM organisation through consistent scope definitions, transition methodology, metrics and lessons learned, advising the other Regional Heads and representing PSPV-AM in the enterprise GCM programme.

Skills and qualifications

• A Bachelor's or advanced degree is required, with a preference for a healthcare, medical or life sciences degree.
• Minimum 12 years of experience in the pharmaceutical industry including line management (to be customised based on country/regional situation), with a high level of exposure to drug safety, clinical operations or research and development project management, and to working in or with local affiliates.
• Meets all applicable local QPPV / PV contact person requirements including education, training and experience, if required for the position.
• Advanced knowledge of PV operations, global and local safety regulations and business planning processes.
• Strong proven leadership capability with well-developed skills in teambuilding, motivating and developing people across multiple countries, and demonstrated collaborative leadership and influence to ensure alignment among key stakeholders.
• Demonstrated success leading transformation or change programmes in a multi-country matrix organisation, including process simplification and digital or AI enablement.
• Experience with AI and digital solutions applied to pharmacovigilance, including an understanding of validation, data privacy and GxP expectations for such solutions.
• Experience working with global capability / shared service organisations and external partners, including scope definition, service level and quality oversight, and transition management.
• Strategic mindset with a proven ability to translate global strategy into an executable regional roadmap and to sustain adoption of new ways of working.
• International experience; accustomed to working cross-culturally, in particular across Intercontinental markets.
• Strong, demonstrated ability to collaborate and effectively influence various functional areas, partners, regions and cultures within a matrix setting to achieve alignment and consensus, and to represent the department and company in a highly professional manner.
• Ability to comprehend, organise and synthesise complex data, identify issues and trends, and develop and implement solutions to achieve management objectives.
• Excellent organisational skills with the ability to prioritise individual and departmental workloads to reliably meet deadlines; comfortable with managing ambiguity.
• Excellent communicator with strong written, oral and presentation skills; good working knowledge of English, ability to speak other languages is also beneficial.

At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential. As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.

Diversity, Equality, and Inclusion

Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.

Learn more at takedajobs.com

Locations

Zurich, Switzerland

Base Salary Range:

CHF212,500.00 - CHF292,160.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time