Region Head, Pharmacovigilance Affiliate RelationsApply Now Email Me Job ID R0012854 Date posted 10/16/2019 Location: Singapore, Singapore
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- The Region Head, Pharmacovigilance Affiliate Relations, is responsible for local Pharmacovigilance (PV) activities in the region, including the management -- direct and functional -- of all Patient Safety Leads (PSLs) in that region and is accountable for ensuring local PV alignment with Global Pharmacovigilance (GPV) and global/regional alignment with Medical Affairs, Regulatory Affairs and Quality.
- Oversees and manages by influence all local individuals that perform PV activities, including those that do not report directly or indirectly into GPV.
- Creates and maintains strong matrix partnering, inclusiveness and collaborative working relationship with Safety colleagues, including Area Medical Directors, Country 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 (LOCs) to ensure procedural and regulatory compliance.
- Establish long term plans and goals together with the Head, PV Affiliate Relations and applicable local and global stakeholders such as the EU QPPV, Marketed Products and Area Medical Affairs Directors, 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 organization to build the reputation of PV within the assigned region.
- Manages through direct lines, or functional reporting, the PSL Area Leads and Direct PSLs for key countries in the assigned region.
- Sets and implements the strategy for the region. Works with other Senior Directors of PV Affiliate Relations to globally align to maintain proficiency in applicable local knowledge of key drug safety regulations. Ensures the maintenance of operational compliance as regulations are changed or modified. Acts upon developments in PV landscape; identifies and supports changes to processes.
- Chair the Regional Pharmacovigilance Forum and set goals, priorities, key performance metrics and long-term plans within the 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 PV activities.
- Collaborates with other functions, including Regulatory Affairs, Medical Affairs and Quality to ensure that LOCs maintain compliance with PV requirements in LOCs that do not have dedicated PV individuals.
- 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 in the LOCs.
- Collaborates with GPV Compliance and the Takeda Quality organization to ensure oversight of all audit/inspection and compliance-related activities and outputs applicable to the region.
- Drives the promotion of PV and the safety of patients with key stakeholders.
- Addresses with local and regional Commercial team and PV Affiliate Relations the resourcing needs and strategies to meet Takeda and local, regional and global PV requirements.
- Ensures oversight of the operating budgets within the region
- Works with the global and local Qualified PV individuals in the region to ensure accuracy of the PV system and the PV Master File (PSMF), both for Growth & Emerging Markets (GEM) region 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 GPV and individual PSLs, and acts as an advocate for the PSLs, and their local operating companies, within the GPV organization.
- Ensures PV and management issues that are escalated within each LOC are addressed.
- Provides leadership for impact analyses of regional specific regulatory changes on Regional/Global PV systems and vice versa.
Scope of supervision
- Direct: 5-10 people.
- Indirect: 20-30 people.
- APAC - Taiwan, Korea, Southeast Asia and Oceania Cluster
- ICMEA - India, CIS, Middle East and Africa
Education, behavioral competencies and skills
- Bachelors degree / Advanced degree. Healthcare or Medical degree preferred.
- Extensive experience in the pharmaceutical industry, with 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 team-building and motivating and developing people. Able to demonstrate 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 issues 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.
- Good working knowledge of English; ability to speak other languages is also be beneficial.
- Comfortable with managing ambiguity.
- Some travel to Takeda’s global sites may be required.