Global PV Operations & Strategy Director

Takeda Pharmaceutical Co.; Kendall Square (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Co. seeks a Director of PV Clinical Operations to oversee outsourced pharmacovigilance activities across trials, ensuring global harmonization, safety data integrity, and regulatory compliance.

You will lead risk-based quality reviews, vendor oversight, and cross-functional collaboration with Clinical Science, Data Management, and Regulatory Affairs to deliver safe, compliant clinical trial operations. Cambridge, MA-based leadership with a focus on continuous improvement.

Qualifications

• Experience in clinical trial pharmacovigilance operations.
• Proficient in risk-based quality reviews of safety data.
• Knowledge of global PV regulations and industry practices.
• Experience in vendor oversight and audits.
• Strong analytical and communication skills.
• Ability to mentor junior team members.
• Ability to work across functions and global teams.

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 to integrate safety requirements.
• Partner with Clinical Science, Data Management, Regulatory Affairs to promote PV standards.
• Lead or support audits and regulatory inspections.
• Drive continuous improvement in collection and evaluation of safety data.
• Maintain knowledge of global PV regulations and mentor junior team members.
• Promote cross-functional awareness of PV processes and standards.

Skills

PV operations

Vendor oversight

Regulatory inspections

Risk-based quality reviews

Data interpretation

Cross-functional collaboration

Mentoring

Job description

Takeda Pharmaceutical Co. seeks a Director of PV Clinical Operations to oversee outsourced pharmacovigilance activities across trials, ensuring global harmonization, safety data integrity, and regulatory compliance.

You will lead risk-based quality reviews, vendor oversight, and cross-functional collaboration with Clinical Science, Data Management, and Regulatory Affairs to deliver safe, compliant clinical trial operations. Cambridge, MA-based leadership with a focus on continuous improvement.