Associate Director, Pharmacovigilance Training & Compliance

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Job Description

Objective & Purpose:

• Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (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 employee training compliance with the LMS.

• Oversees the coordination, including the collection, tracking, and trending of key PV Compliance metrics for the monthly cross-functional Compliance Metrics Oversight Committee meetings.

• Interfaces and collaborates cross-functionally with other functions including but not limited to PSPV sub-functions, Documentation & Learning Excellence (DLE), Global Regulatory Affairs (GRA), Global Development Organization (GDO), Clinical Quality (CQA), and the PV & Medical Quality (PVMQ) functions.

• Leads and/or supports Training and Compliance related projects and/or activities, as assigned.

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 to meet global PV requirements.

• Supports new employee onboarding and training activities.

• Monitors, interprets, and communicate regulatory requirements and ensure global standards, SOPs, and all associated documentation are in line with global regulatory requirements and global PV SOPs.

• Oversees the coordination and data organization of the monthly Compliance Metrics Oversight Committee (CMOC) meetings, including the collection, tracking, and trending of key compliance metrics including but not limited to: Health Authorities submission metrics. End-to-end (E2E) metrics for key cross-functional processes such as the Reference Safety Information (RSI), Social Digital Media, and Market Research/Patient Support Programs (MR/PSP) processes. Quality metrics for Individual Case Safety Reports (ICSR), Agregate Safety Reports (ASR), and Signal Evaluation Reports (SER). PV Suppliers Key Performance Indicators (KPIs). PV Training Compliance.

• Serves as the compliance lead for PSPV-owned Quality Events (QEs), Corrective and Preventive Actions (CAPAs), and Effectiveness Checks (ECs), ensuring timely and effective identification, mitigation, prevention, monitoring, and tracking of PV-related compliance issues. Facilitates their resolution through collaborative cross-functional efforts with stakeholders and compliance leads across and beyond PSPV.

• Supports compliance-related activities, as needed, including but not limited to: PV Regulatory Intelligence activities. Audits and inspection-related activities, e.g., coordination of document requests and responses, QC review of documents, and inspection preparation activities or as a compliance and training Subject Matter Expert (SME).

• Ensures that adequate processes are in place to maintain current knowledge of compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.

Education & Competencies:

• Bachelor’s degree in a scientific discipline or related field, preferably Health Care Professional; post-graduate degree or equivalent a plus.

• Minimum of 5 years prior experience in pharmaceutical industry in a drug safety/pharmacovigilance global setting

• Experience in developing procedural documents and training materials.

• Knowledge of FDA/EU regulations, and ICH guidelines for GVP and GCP with practical experience in the interpretation and implementation of PV regulations. Ability to interpret PV regulations, analyze gaps, and identify opportunities for improvement within PSPV.

• Ability to work and collaborate in a global environment with cross-functional teams, with excellent interpersonal skills, assertiveness, and team spirit; ability to identify and resolve conflicts, with support from line manager

• 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 with excellent project management and organization skills

• 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:

Boston, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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

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