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Associate Director, Standards and Intelligence, in partnership with the Director, develops strategy and oversees the operational activities of global PV Standards & Intelligence ensuring alignment with global strategic initiatives related to quality, compliance and training. Principal responsibilities include but are not limited to:
- Development and leadership of the following activities at a global level in collaboration with Director:
- PV Standards in alignment with regulatory guidelines and good Pharmacovigilance practices
- Non GxP Guidance
- Completeness and accuracy of global PV system documents required by regulators including the Pharmacovigilance System Master File (PSMF)
- CAPA identification and implementation
- Regulatory PV intelligence
- Global strategy for maintenance of PV standards to remain compliant with evolving PV regulations
Management of regional team members in the Standards and Intelligence Group including talent management activities such as annual reviews, performance management, succession planning and employee development and retention of direct reports
Processes and Procedures
Provide leadership and oversight to global PV Standards activities including procedure/process preparation, writing, content finalization, and maintenance, with support from subject matter experts, external functional areas, and QA
- Together with Director, develop strategy for the PV Standards and Intelligence function ensuring processes and documents are in place to comply with GVP and global regulatory requirements.
- Provide leadership for reviewing and providing input into global PV SOPs and other relevant Takeda functional area SOPs to meet global PV requirements
- Monitor, interpret, and communicate regulatory requirements and ensure global standards, SOPs, and all associated documentation is in line with global regulatory requirements and global PV SOPs
- Serve as the key contact in region for PV Standards and intelligence related issues and advise the potential issues and solutions to the upper Management
- Develop globally aligned processes for capturing regulator required PV data for inspections including the PSMF.
- Ensure that regional PV staffs are trained effectively to perform their roles and responsibilities with the partnership with QA D&T.
- Partner with the PV compliance team to support PV audits/Inspections and ensure functional readiness with compliance and training team.
- Drive CAPA processes, identification of CAPAs in response to audits/inspections, and implementation of CAPAs into updated PV procedures.
- Responsible for maintaining knowledge of global PV regulations
- Keep current with and anticipate changing global PV regulatory landscapes in order to proactively manage applicable changes to global PV standards
- Develop and implement methods to ensure PV regulations are interpreted and incorporated into the process.
- Provide leadership for evaluating the regulations that impact to the current process/procedure and to keep updated in order to meet the regulatory requirement
Perform other tasks assigned by Director, PV Standards & Intelligence to assist in departmental activities
- Manage resolution of issues and escalate issues / problems to senior management as needed
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Professional Profile Education and experience
Proven ability to work in international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / caching skills
- BS, RPH, RN HCP, or Life Science required; PhD or PharmD degree preferred
- In depth knowledge and comprehension of Pharmacovigilance regulations and ability to interpret multiple requirements into concise clear instructions
- Reasonable experience in participating or supporting PV audit/Inspection.
- Works strategically to realise organizational goals
- Critical thinking and decision-making skills
- Exercise independent judgment
- Understanding Takeda business needs with global business perspective and professional attitude
- Excellent level of computer literacy with Microsoft applications
- Excellent organization skills and ability to prioritize
- Demonstrate integrity
- Relate well to people at all levels
- 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
- Routine demands of an office based environment.
- Estimated 5-10 times per year, including possible international travel
ADDITIONAL US SPECIFIC INFORMATION:
- Minimum 8 years pharmaceutical or health care related industry experience; previous experience working in global environment preferred.
- Minimum 5 years Patient Safety or relevant experience in the pharmaceutical/biotechnology industry
- Minimum of 2 years of line management or matrix management required
- Significant knowledge of Quality Management/QA and standards development
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