Director, Global Pharmacovigilance 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

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