Sr Manager, Patient Safety & Pharmacovigilance, Standards & Training; Remote

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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 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 communicates regulatory requirements and ensures global standards, SOPs, and all associated documentation are in line with global regulatory requirements and global PV SOPs.

• Contributes as a member to assigned projects and provides strategic insight at the global level.

• Participates in and supports PV audit/inspection and ensures readiness with compliance and training team.

• Escalates 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 the pharmaceutical industry in a drug safety/pharmacovigilance global setting.

• Experience in 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

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For

Location:

USA - MA
- Virtual

U.S. Base Salary Range:

$ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be…