- Provides strategic leadership and oversight for the cross-functional management for aggregate safety reports.
- Ensures aggregate reporting compliance for Global PV at Takeda.
- Drives vendor requirements and vendor quality management for aggregate safety reporting.
- Oversee global management and preparation of aggregate safety reports for investigational and marketed products.
- Ensure Vendor execution and training for preparation of periodic aggregate safety reports.
- Establish functional specifications for deliverables from the Global safety database for periodic aggregate safety reports.
- Manage compliance with all regulatory requirements for periodic aggregate safety report deliverables. Ensure vendor compliance with Takeda requirements.
- Partners cross-functionally internally to define reporting and submission requirements to enable vendor resource planning to deliver all safety reports.
- Oversee aggregate safety reporting schedules.
- Drive preparedness for regulatory authority inspection and internal audits for aggregate reporting processes. Serve as the primary functional interface from Pharmacovigilance for subject matter expertise on aggregate safety reporting content.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor s degree required. Advanced degree preferred.
- Substantial pharmaceutical or health care related industry experience required
- Must have high level of exposure in preparation and submission of periodic aggregate safety reports in Pharmacovigilance environment
- Demonstrated experience in people management and well-developed skills in team building, motivating and developing people ideally within an Aggregate reporting function.
- Expert knowledge of Global regulatory requirements
- Experience in vendor management for outsourced activities
- Demonstrate integrity
- Motivate and empower others
- Work productively in a high pressure environment
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate
- Project Management abilities
- Strong knowledge of business area and interactions with strong regulatory environment and ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety database
- Take initiative and autonomous action
- Able to lead teleconferences and meetings
- Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
Some travel within Takeda global sites may be required.
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