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Senior Director Affiliate Relations - United Kingdom
Posted on : 19 September 2017
The Senior Director Affiliate Relations is responsible for local pharmacovigilance activities in the assigned region, including the management, direct or functional, of all Drug Safety Officers (DSO) 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 VP, EU QPPV, EU Compliance, EU Marketed Products and Affiliate Relations and Area Medical Affairs Director, and provide leadership and vision for PV related activities within their region. Chairs the Regional Pharmacovigilance Forum, for their region and 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 DSO Area Leads, and Direct DSOs for key countries, in their assigned region.
- Sets and implements the strategy for their region (EUCAN/Emerging Markets); 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 EU 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, EU Compliance, the EU QPPV 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 VP, EU QPPV, EU Compliance, EU Marketed Products and Affiliate Relations the resourcing needs and strategies to meet Takeda and local, regional and global PV requirements.
- In collaboration with the PV Strategy and Business Planning group, will ensure oversight of the operating budgets within their region
- Works with the EU QPPV, and Qualified Pharmacovigilance Individuals in the region to ensure accuracy of the EU pharmacovigilance system and the Pharmacovigilance Master File (PSMF), both for the EU and other regions as applicable
- Directs DSO Area Leads to ensure optimal knowledge transfer within and across regions for initiatives and LOC support activities.
- Promotes clear communication between Global PV and individual DSOs, and acts as an advocate for the DSOs, and their local operating companies, within the Global Pharmacovigilance organisation.
- Ensures PV and management issues that are escalated in each LOC are addressed
Some travel to Takeda’s global sites may be required.
Education, Behavioural, Competencies and Skills
- Bachelors degree/ Advanced degree. Medical Degree preferred.
- Extensive experience in the pharmaceutical industry, with at high level of exposure to drug safety/clinical operations or research and development project management and working in or with local affiliates.
- 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, particularly European pharmacovigilance regulations.
- International experience; used 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 large and global change agendas
- 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.
- Good working knowledge of English; ability to speak other languages would also be beneficial.
- Comfort with ambiguity