Regional Head, PSPV-Affiliate Management APAC, ME & CIS Zurich, Canton of Zurich Category: Drug Safety

Job description

Regional Head, PSPV-Affiliate Management APAC, ME & CIS Zurich, Canton of Zurich Apply Now Job ID R0193875 Category Drug Safety Subcategory Research & Development Business Unit Research & Development Job Type Full time 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’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. 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 al