Associate Director, Pharmacovigilance Training & Compliance

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 153,000 - 242,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks an Associate Director for Pharmacovigilance Training & Compliance. This role involves managing training programs, ensuring compliance with regulations, and collaborating across functions to enhance safety practices. The ideal candidate will possess a scientific background, strong project management skills, and a proactive approach to compliance in a global setting.

Benefits

401(k)

Tuition Reimbursement

Paid Time Off

Well-being Programs

Qualifications

• Minimum 5 years’ experience in pharmaceutical drug safety/pharmacovigilance.
• Experience developing procedures and training materials.

Responsibilities

• Ensures adequate training support in a PV regulated environment.
• Manages the Learning Management System for training compliance.
• Supports global PV Standards activities and compliance.

Skills

Collaboration

Project Management

Attention to Detail

Education

Bachelor’s degree in a scientific or related field

Tools

Microsoft Office

Job description

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Associate Director, Pharmacovigilance Training & Compliance

View more categories View less categories Discipline Administration ,Clinical ,Drug Safety/Pharmacovigilance Required Education Bachelors Degree Position Type Full time Hotbed Genetown ,Best Places to Work

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Job Description

Objective & Purpose:

• Ensures adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a PV regulated environment.
• Supports development and delivery of PSPV employee training to ensure appropriate curriculum for their roles.
• Manages the Learning Management System (LMS) for controlled development, delivery, and tracking of training; monitors employee training compliance.
• Oversees coordination, collection, tracking, and trending of PV compliance metrics for monthly cross-functional meetings.
• Collaborates cross-functionally with PSPV sub-functions, Documentation & Learning Excellence (DLE), Global Regulatory Affairs (GRA), GDO, CQA, and PVMQ.
• Leads/supports Training and Compliance projects and activities as assigned.

Accountabilities:

• Supports global PV Standards activities, including procedure and process preparation, writing, and maintenance, with input from SMEs, external areas, and QA.
• Supports onboarding and training of new employees.
• Interprets and communicates regulatory requirements, ensuring alignment with global standards, SOPs, and documentation.
• Coordinates and organizes data for monthly Compliance Metrics Oversight Committee (CMOC) meetings, including collection, tracking, and trending of key metrics such as Health Authorities submissions, E2E process metrics, quality metrics for ICSRs, ASRs, SERs, PV KPIs, and training compliance.
• Serves as compliance lead for PSPV-owned QEs, CAPAs, and ECs, ensuring timely mitigation and resolution through cross-functional collaboration.
• Supports compliance activities including PV Regulatory Intelligence, audits, inspections, document coordination, QC review, and SME roles.
• Maintains current knowledge of PV regulations and evolving compliance requirements.

Education & Competencies:

• Bachelor’s degree in a scientific or related field; post-grad or equivalent a plus.
• Minimum 5 years’ experience in pharmaceutical drug safety/pharmacovigilance in a global setting.
• Experience developing procedures and training materials.
• Knowledge of FDA/EU regulations, ICH GVP, GCP; ability to interpret PV regulations and identify improvement opportunities.
• Strong collaboration skills in a global environment, with excellent interpersonal, assertiveness, and conflict resolution skills.
• Effective time and priority management, attention to detail, project management skills.
• Proactive, independent work style, capable of managing multiple priorities.
• Proficiency with Microsoft Office applications.

Takeda Compensation and Benefits:

We value fair compensation and transparency. For Boston, MA, the U.S. base salary range is $153,600 - $241,340, depending on experience and qualifications. Benefits include incentives, insurance, 401(k), tuition reimbursement, paid time off, holidays, and well-being programs. Eligible employees may accrue up to 80 hours of sick leave and 120 hours of vacation annually.

EEO Statement:

Takeda is committed to diversity and equal opportunity employment, prohibiting discrimination based on race, color, religion, sex, sexual orientation, gender identity/expression, parental status, national origin, age, disability, citizenship, genetic info, marital status, veteran status, or other protected categories.

Locations: Boston, MA

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: Yes

Massachusetts law prohibits requiring or administering lie detector tests as a condition of employment; violations may lead to penalties.

Company

Takeda has evolved over 240 years, fostering innovation across global regions. We are committed to patients, our people, and the planet, with a history rooted in integrity and patient-first values. Join us to develop your career and make a difference.

Website: https://www.takeda.com/

Location: 650 East Kendall Street, Cambridge, MA 02421, United States