Sr. Manager Global Safety Database Configuration

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Global Safety Database Configuration in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

• The ideal candidate will serve as subject matter expert and lead business administration of safety database and develop/manage code changes to the safety database.
• They will perform a critical role in optimal operation of the safety database and helps drive digital transformation in pharmacovigilance by adopting new technologies for automation/intelligence while maintaining regulatory compliance.
• They will play a key role as SME during inspections.

POSITION ACCOUNTABILITIES:

• Serve as technical configuration expert for the PV TechOps team on administration of business changes such as products, licenses, studies, reporting, codelists, etc within safety database.
• Monitor the performance of safety systems, troubleshoot data discrepancies, system errors, and identify process inefficiencies.
• Manage IT change control, identification and appropriate escalation of issues
• Develop and maintain SDLC documents including but not limited to requirement specifications, functional specifications and validation documents
• Lead E2B program expansion based on business needs and interpretation of global regulatory changes
• Support MedDRA upgrade and related activities
• Perform data extraction and analysis using SQL
• Create SQL DML and DDL scripts for enhancement of Safety database to meet evolving business needs
• Support the integration of new data sources and automation initiatives
• Provides an effective balance between IT standards and strategies with business needs to guide well-informed decisions.
• Strategize and plan for PV systems enhancements/projects in support of global business initiatives and regulatory requirements
• Communications with regulatory agencies/partners as appropriate
• Responsible for vendor management activities
• Maintain PV systems compliance in accord with global regulations
• Provide support to PV Systems regulatory inspection and internal audits

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelor’s degree required but Master’s preferred in computer science, information systems, life sciences or related technical discipline
• Ability to handle system support, data management, and reporting independently.
• Proven coding experience with Oracle SQL and Argus Safety database and/or other safety databases like ARISg or Veeva.
• Proficiency in Python for scripting, data manipulation, and process automation and/or other automation technologies is preferred
• Knowledge of data visualization tools such as Tableau/Spotfire is preferred
• Knowledge of drug safety regulations (e.g., ICH, FDA, EMA guidelines) and pharmacovigilance data (e.g., case processing, MedDRA coding) is highly desirable
• Knowledge of data integrity, system validation, and computer system compliance (21 CFR Part 11, EU GVP)
• Experience in matrix management, and well-developed skills in teambuilding, motivating and developing people
• Demonstrated skills in negotiation and consensus decision making
• Able to interact with personnel from other functional areas and externally to the company at all levels and to represent the department and company in a professional manner

ADDITIONAL INFORMATION:

• Minimum 7 years of pharmaceutical or health care related industry experience required
• Minimum of 5 years of experience in Pharmacovigilance
• Minimum of 5 years of experience with safety data, databases and computerized systems required

This position is currently classified as “ hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Empowering Our People to Shine

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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:

Boston, MA

U.S. Base Salary Range:

$137,000.00 - $215,270.00

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 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

Boston, MA

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.