The Senior Director Affiliate Relations is responsible for local pharmacovigilance activities in the assigned region, including the management, direct or functional, of all Patient Safety Leads (PSL) in that region and is accountable for ensuring local PV alignment with GPV and global / regional alignment with Medical Affairs, Regulatory Affairs and Quality.
Oversees and manages by influence, all local individuals that perform pharmacovigilance activities, including those that do not report directly or indirectly into Global Pharmacovigilance.
Creates and maintains strong matrix partnering, inclusiveness and collaborative working relationship with safety colleagues, including Area Medical Directors and local Medical Directors and other colleagues supplying sources of safety information (within both R&D and Commercial organisations).
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 Area 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 Takeda and local, regional and global PV requirements.
Influences Internal and external stakeholders, both in R&D and the commercial organisation to build the reputation of pharmacovigilance within their assigned region.
Manages through direct lines, or functional reporting, the PSL Area Leads, and Direct PSLs for key countries, in their assigned region.
Sets and implements the strategy for their region; working with other Senior Director Affiliate Relations to globally align to maintains 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
Chair the Regional Pharmacovigilance Forum and set the goals, priorities, key performance metrics and long-term plans within their Region.
Ensures regional strategies incorporate global and local QPPV requirements.
Collaborates with the Area and Country Medical Directors to ensure the development of individual DSOs including those that are not fully assigned to pharmacovigilance activities.
Collaborates with other functions, including Regulatory Affairs, Medical Affairs and Quality to ensure that LOCs maintain compliance with pharmacovigilance requirements in LOCs that do not have dedicated pharmacovigilance individuals.
Collaborates with PV Compliance, Standards and Training as well as the Takeda Quality organisation 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 organisation 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 region
Works with the global and local Qualified Pharmacovigilance Individuals in the region to ensure accuracy of the pharmacovigilance system and the Pharmacovigilance Master File (PSMF), both for the EU and other regions as applicable
Directs PSLs to ensure optimal knowledge transfer within and across regions for initiatives and LOC support activities.
Promotes clear communication between Global PV and individual PSLs, and acts as an advocate for the PSLs, and their local operating companies, within the Global Pharmacovigilance organisation.
Ensures PV and management issues that are escalated in each LOC are addressed
Provides leadership for impact analyses of regional specific regulatory changes on Regional / Global PV systems and vice versa.
Job ID R0014323