Manager, PV Training is responsible for managing training and training compliance activities and supports the development and implementation of the strategic vision and initiatives of global PV Training.
Principal responsibilities include but are not limited to:
- Guiding design, development and provision of training for PV procedures, systems, and practices within global PV, for stakeholder functions, and across local operating companies.
- Lead training gap analyses and implement training to fill gaps.
- Perform root cause analysis and implementation of process improvement strategy related to PV training scope to ensure alignment with GPV business objectives.
- Lead projects and provide regional insights to global training projects where applicable.
- Develop surveys and assessments to measure training effectiveness.
- Partner with key stakeholders in PV and QA to support the development and implementation of effective PV training compliance.
- Represents Training functional internally and externally
- Provide leadership for training related issues and advise PV management team of potential issues and solutions
- Serve as departmental training SME and provide training strategy and content for all relevant areas, excluding the safety database.
- Review training procedures for local and regional offices in support of global alignment activities.
- Prepare data, interpret and perform impact analysis regarding metrics for PV training compliance.
- Manage the investigation of non-compliance and implementation of corrective
- measures where required in the scope of PV training activities.
- Develop and distribute regular reports regarding training compliance activities to key stakeholders.
- Author and review quality documents supporting training processes.
- Perform impact analysis for PV compliance strategies and working practices, including input into safety exchange agreements, CRO oversight, SOPs, and other pertinent PV processes.
- Guide preparation of training content design, development, and implementation of DSO Training curriculum for Local Operating Companies (LOCs)
- Partners with LOCs and Drug Safety Officers (DSOs) on local inspection/audit training CAPA needs
- Support global efforts to ensure PV regulatory inspection or internal audit readiness for dedicated PV or GCP inspections/audit.
- Develop and oversee training matrices and the periodic updating of those matrices per SOP-PV-004 for the PV function.
- Responsible for management of PV training schedule.
- Serve as the contact point for PV training needs, and SME for audits/inspections as needed
- Addresses CAPA findings as needed
- Liaise with QA Documentation and Training Department as required
- Escalate issues/problems to management as needed.
- Perform other tasks assigned by manager to assist in departmental activities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS, RPH, RN HCP, or Life Science required; Post-graduate degree or equivalent preferred
- In depth knowledge and comprehension of the Pharmaceutical industry, Pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
- Excellent knowledge of instructional design in the area of regulated training content and curriculum
- Works strategically to realize 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 (e.g. PowerPoint, Word, Excel)
- 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
- Ability to identify proactively and anticipate risk of non-compliance in a complex environment
- Knowledge of compliance international Regulations and ICH environment foundations
- 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
- 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
Routine demands of an office based environment.
Estimated 0-5 times per year, including possible international travel.
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