Sr. Manager Global Safety Database Configuration

Takeda Pharmaceutical Company • Boston, MA

71d • $137,000 - $215,270 • Hybrid

About The Position

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.

Requirements

• 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.

Responsibilities

• Serve as subject matter expert and lead business administration of safety database and develop/manage code changes to the safety database.
• Perform a critical role in optimal operation of the safety database and help drive digital transformation in pharmacovigilance by adopting new technologies for automation/intelligence while maintaining regulatory compliance.
• Play a key role as SME during inspections.
• 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.
• Provide 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.
• Communicate 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.

Benefits

• U.S. Base Salary Range: $137,000.00 - $215,270.00
• Eligible for short-term and/or long-term incentives.
• Eligible to participate in medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees