Sr Manager, PSPV Standards & Training (Remote)

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Job Description

Objective / Purpose:

• Ensures adequate training support to all functional areas within PSPV in a Pharmacovigilance (PV) regulated environment.

• Supports the development and delivery of PSPV employee training to ensure they possess the appropriate curriculum necessary for their role and function.

• Manages the Learning Management System (LMS) to ensure controlled development, delivery, and deployment of training.

• Monitors and tracks training compliance with the LMS.

• Provides Standards & Training subject matter insights within and outside of the PSPV function.

• Interfaces and collaborates with cross-functionally with other functions including but not limited to PSPV sub-functions, Documentation & Learning Excellence (DLE), PV Medica Quality (PVMQ)

Accountabilities:               

• Supports global PV Standards activities including procedure/process preparation, writing, content finalization, and maintenance, with support from subject matter experts, external functional areas, and QA.

• Supports new employee onboarding and training activities.

• Reviews and provides input into global PV SOPs and other relevant Takeda functional area Standard Operating Procedures (SOPs )to meet global PV requirements

• Monitors, interprets, and communicate regulatory requirements and ensure global standards, SOPs, and all associated documentation is in line with global regulatory requirements and global PV SOPs

• Contributes as the member to assigned projects and provide strategic insight at global level

• Participate in and support for PV audit/Inspection and ensure its readiness with compliance and training team

• Escalate issues / problems to line manager as needed.

Education & Competencies (Technical and Behavioral):

• Bachelor’s degree in a scientific discipline or related field, preferably Health Care Professional

• Minimum of 5 years prior experience in pharmaceutical industry in a drug safety/pharmacovigilance global setting

• Experience in with training adult learners and developing procedural documents and training materials.

• Ability to work and collaborate in a global environment with cross-functional teams, with excellent interpersonal skills, assertiveness, and team spirit.

• Ability to manage both time and priority constraints with strong attention to detail in establishing priorities and meeting deadlines.

• Ability to lead teleconferences and meetings.

• Proactive, takes initiative, works independently, and manages multi-priority tasks.

• Excellent computer literacy, especially with Microsoft applications

Takeda Compensation and Benefits Summary

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