Senior Director, Pharmacovigilance Operations

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

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Director of PV Clinical Operations to provide functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup, CRO training, and vendor management.

You will work with stakeholders worldwide to harmonize PV operations, ensure regulatory compliance, and deliver critical safety activities while mentoring the PV team.

Qualifications

• Functional expert within Takeda's global Pharmacovigilance organization.
• Experience in clinical trial PV operations and outsourced activities.
• Knowledge of global PV regulations and industry practices.

Responsibilities

• Provide program-level oversight of outsourced PV activities across trials.
• Conduct risk-based quality reviews of safety deliverables and documentation.
• 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.
• Collaborate with Clinical Science, Data Management, Regulatory Affairs and other functions to promote PV standards and compliance; lead audits/inspections as needed.
• Drive continuous improvement in collection, processing, documentation and evaluation of safety data.
• Mentor junior team members and promote cross-functional awareness of PV processes and standards.

Skills

PV operations oversight

Risk-based quality reviews

Global PV regulations

Vendor oversight

Audits & regulatory inspections

Analytical skills

Cross-functional collaboration

Mentoring junior staff

Job description

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Director of PV Clinical Operations to provide functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup, CRO training, and vendor management.

You will work with stakeholders worldwide to harmonize PV operations, ensure regulatory compliance, and deliver critical safety activities while mentoring the PV team.