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Sr Manager, PSPV Standards & Training (Remote)

Remote
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  • Job Level: Senior
  • Travel: Minimal (if any)

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.

Job ID R0143790 Date posted 02/04/2025 Location 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

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:

$133,000.00 - $209,000.00

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 eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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During my 20-year journey here, I’ve been fully supported by my colleagues, and I can’t say enough about our rich internal talent and the long-standing values that drive our decisions as we work to develop important medicines for the patients we serve.

Doug Coffman - Head, R&D Asset Transition & Integration Office, R&D Regional & Business Operations

When making any type of decision, the first thing we ask is 'how will this impact patients?’ Ultimately, we’re laser focused on the best interests of the patient, and I truly believe we follow through on that.

Meredith Culp - VP, Head of Neuroscience Therapeutic Area Strategy & Operations and Head of Global Development Integration Office

Our culture and shared values make us like a family here at Takeda. It doesn't feel like work when you're doing something you love with people you love, and when your outcome is really fantastic.

Alison Handley, Head, Center for External Innovation

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