PV Country Lead

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Job Description

OBJECTIVES:

• Responsible for pharmacovigilance activities in the assigned country, cluster, region, including the management, direct or functional, of all PV staff and is accountable for ensuring local PV alignment with GPSE and global/regional/local alignment with Medical Affairs, Regulatory Affairs, Quality and Commercial.

ACCOUNTABILITIES:

• Performs local QPPV and/or local PV contact person activities and is trained to do so, where required as per regulations.

• Oversees and manages all local individuals that perform pharmacovigilance activities, including those that do not report directly or indirectly into GPSE (vendors, contractors), as required.

• Creates and maintains strong matrix partnering, inclusiveness and collaborative working relationship with safety colleagues, including Local/Cluster/Regional Medical Directors and other colleagues supplying sources of safety information (within both R&D and Commercial organizations).

• Responsible for the implementation of Global, Regional and Local strategies in the Local Operating Countries (LOC) to ensure procedural and regulatory compliance.

• Establish long term plans and goals together with the Head of Affiliate Relations, and applicable local and global stakeholders such as the EU QPPV, Marketed Products and Medical Affairs Director, and provide leadership and vision for PV related activities within their region. Collaborates with Medical Affairs, Regulatory Affairs and Quality to proactively address pharmacovigilance needs for the region, ensuring cross functional alignment.

• Ensures financial accountability and resourcing levels meet corporate local, regional and global PV requirements.

• Influences internal and external stakeholders, both in R&D and the commercial organization to build the reputation of pharmacovigilance within their assigned region.

• Sets and implements the strategy for their country/cluster/region; working with other Senior Director Affiliate Relations to globally align and maintain proficiency in applicable local knowledge of key drug safety regulations and ensures the maintenance of operational compliance as regulations are changed or modified. Act upon developments in PV landscape; identifying and supporting changes to processes.

• Set goals, priorities, key performance metrics and long-term plans within their country/Cluster/Region.

• Collaborates with PV Compliance, Standards and Training as well as the Takeda Quality organization to ensure a high level of PV compliance and training compliance at all LOCs in their region. Develop strategies to align GPV SOPs, processes, and tools within their region to meet operational and training needs of the PV staff at the LOCs.

• Collaborates with Global PV Compliance and the Takeda Quality organization to ensure oversight of all audit/inspection and compliance related activities and outputs applicable to their region.

• Drives the promotion of pharmacovigilance and the safety of patients with key stakeholders.

• Addresses with local and regional Commercial team and Affiliate Relations the resourcing needs and strategies to meet Takeda and local, regional and global PV requirements.

• Ensures oversight of the operating budgets within their country/cluster/region

• Directs PSLs to ensure optimal knowledge transfer within and across regions for initiatives and LOC support activities.

• Promotes clear communication between Global PV and LOC/Cluster/Region.

• Provides leadership for impact analyses of country/cluster/region specific regulatory changes on Global PV systems

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree/ Advanced degree. Healthcare or Medical Degree preferred.

• Extensive experience in the pharmaceutical industry including line management ( 7-10 year minimum- to be customized based on country/regional situation), with a high level of exposure to drug safety/clinical operations or research and development project management and 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).

• Strong proven leadership capability with well-developed skills in teambuilding, motivating and developing people and able to demonstrates collaborative leadership and influence necessary to ensure alignment among key stakeholders.

• Advanced knowledge of PV operations, global safety regulations and business planning processes

• International experience; accustomed to working cross-culturally

• Self-driven, team player in a cross-functional environment. Clear track record of delivery.

• Advanced skills in designing and developing global project plan, coordinating and tracking global projects and administrative skills.

• 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 coordinate issue resolution and make global decisions on complex matters in a timely manner.

• Strong proven ability to manage global changes

• Ability to comprehend, organize and synthesize complex data, identify issues and trends and develop and implement solutions to achieve management objectives.

• Excellent organization skills and ability to prioritize individual and departmental workloads to reliably meet deadlines.

• Excellent communicator with strong written, oral and presentations skills.

• Fluent in Dutch, and English and very good French communication

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