Sr Manager, Patient Safety & Pharmacovigilance, Standards & Training (Remote)

Initial Therapeutics, Inc.; United States; Remote; USD 133,000 - 209,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Tuition reimbursement

Paid volunteer time off

Paid vacation

Sick leave

Well-being benefits

Job summary

An established industry player is seeking a dedicated professional to enhance training support within the Pharmacovigilance sector. This role involves managing training initiatives, ensuring compliance with global standards, and collaborating cross-functionally. You will play a crucial part in onboarding new employees and developing training materials that align with regulatory requirements. If you are proactive, detail-oriented, and possess strong interpersonal skills, this opportunity offers a chance to make a significant impact in a dynamic environment focused on drug safety and quality assurance.

Qualifications

• 5+ years in the pharmaceutical industry with drug safety experience.
• Experience in training adult learners and developing training materials.

Responsibilities

• Ensure training support in a regulated environment.
• Monitor compliance and track training using LMS.
• Support global PV standards and onboarding activities.

Skills

Pharmacovigilance

Training development

Interpersonal skills

Project management

Attention to detail

Initiative

Education

Bachelor's degree in a scientific discipline

Tools

Learning Management System (LMS)

Microsoft applications

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 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:

$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-term incentives. 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 of 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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