Director, PV Clinical Operations

Takeda Pharmaceutical Company Limited; Cambridge (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Company Limited seeks a Director of PV Clinical Operations to lead outsourced pharmacovigilance activities across clinical trials, ensuring harmonized global operations and strong safety data management. You will mentor teams, drive process improvements, and collaborate across Clinical Science, Data Management, Regulatory Affairs, and CROs.

The role emphasizes risk-based quality oversight, audit readiness, and regulatory compliance, with a focus on delivering robust safety

Qualifications

• Skilled in clinical trial pharmacovigilance operations and oversight of outsourced activities.
• Proficient in risk-based quality reviews of safety deliverables and documentation.
• Knowledgeable about global PV regulations and industry practices.
• Experience in vendor oversight and proactively addressing operational risks.
• Experience supporting audits and regulatory inspections, including timely responses.
• Strong analytical and cross-functional communication skills.

Responsibilities

• Conduct risk-based quality reviews of outsourced deliverables including SAE reconciliation and eTMF documentation.
• Review PV input into key study documents and safety reporting instructions.
• Engage with vendor PV Operations Leads to monitor performance and mitigate risks.
• Represent PV Operations on global program and study teams for safety integration.
• Promote PV standards and regulatory compliance across functions; lead or support audits/inspections.
• Drive improvements in collection, processing, documentation, and evaluation of safety data.
• Mentor junior team members and share PSPV process knowledge.

Skills

PV operations

Risk-based quality reviews

Global PV regulations

Vendor oversight

Audits & regulatory inspections

Cross-functional collaboration

Data interpretation & analysis

Mentoring juniors

Program governance

Stakeholder management

Job description

Job Description

About the role:

The Director, PV Clinical Operations provides functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup and conduct, CRO training, and ongoing vendor management. This role involves partnering with stakeholders within and outside PV to ensure globally harmonized operations, consistent application of PV principles and standards, and effective delivery of critical clinical trial safety activities to support Takeda's mission.

How you will contribute:

• Conduct risk-based quality reviews of outsourced deliverables, including SAE reconciliation, SAE forms and completion guidelines, protocol safety sections, and eTMF documentation.
• Review and provide PV input into key study documents and safety reporting instructions.
• Maintain direct engagement with vendor PV Operations Leads to monitor performance and identify, elevate, and mitigate study and program level risks.
• Represent PV Operations on global program and study teams to ensure appropriate integration of safety requirements.
• Partner with Clinical Science, Data Management, Regulatory Affairs, and other functions to promote consistent PV standards, processes, and regulatory compliance. Lead or support study- and program-specific audits and regulatory inspections.
• Drive continuous improvement in the collection, processing, documentation, and evaluation of clinical trial safety data.
• Maintain current knowledge of global PV regulations and industry practices while mentoring junior team members.

Skills and qualifications:

• Skilled in clinical trial pharmacovigilance operations, providing functional expertise and oversight of outsourced activities.
• Proficient in risk-based quality reviews of clinical trial safety deliverables and documentation.
• Knowledgeable in global PV regulations and industry practices, supporting consistent application of PV standards.
• Skilled in vendor oversight, proactively identifying and addressing operational risks.
• Experienced in supporting audits and regulatory inspections, including preparation of timely responses.
• Strong critical thinking and analytical skills, with the ability to make high-level decisions in cross-functional and global environments.
• Ability to review, analyze, interpret, and present complex data to a high standard. Strong interpersonal communication skills, working effectively with internal and external stakeholders at all levels.
• Good cross-cultural understanding and experience.
• Excellent organizational skills, prioritizing individual and departmental workloads and managing multiple critical issues simultaneously.
• Demonstrated negotiation and consensus decision making skills.
• Able to mentor junior team members and promote cross-functional awareness of PSPV processes and standards.

As a functional expert within Takeda's global Pharmacovigilance organization, you possess in-depth expertise in clinical trial PV operations and work effectively across related functions. You're adept at anticipating cross-therapeutic area risks and process gaps, recommending improvements, and developing practical solutions. Your role involves partnering across functions and with CROs to strengthen operational quality, compliance, and integrated ways of working.

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:

Cambridge, MA

U.S. Base Salary Range:

$177,000.00 - $278,080.00

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.

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

Cambridge, 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.