Senior PV Process Lead — Strategy & Global Excellence

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda Cambridge, MA invites a Senior Director, Pharmacovigilance Process Lead to oversee end-to-end PV processes, shaping strategy and ensuring regulatory compliance. You will partner with Regulatory, Quality, Global Development Operations and others to drive governance and continuous improvement.

In this hybrid role, you will own process documentation, training materials, and CAPA coordination, leading enterprise PV initiatives and safeguarding patient safety across regions.

Qualifications

• 10+ years in the pharmaceutical industry with PV focus.
• Senior leadership experience and matrix team management.
• Strong partnerships with cross-functional stakeholders at enterprise level.
• Excellent planning, execution, and communication skills.

Responsibilities

• Owns end-to-end PV processes, setting strategy and oversight.
• Builds relationships with Regulatory, Quality Assurance, and Global Development Ops.
• Champions governance, roles, and forums for collaboration and accountability.
• Maintains procedural documents, templates, training materials and toolkits.
• Provides PV oversight for audits, CAPAs, and Change Controls.

Skills

Pharmacovigilance

Leadership

Cross-functional collaboration

Regulatory knowledge

Strategic thinking

Education

Bachelor's degree

Job description

Takeda Cambridge, MA invites a Senior Director, Pharmacovigilance Process Lead to oversee end-to-end PV processes, shaping strategy and ensuring regulatory compliance. You will partner with Regulatory, Quality, Global Development Operations and others to drive governance and continuous improvement.

In this hybrid role, you will own process documentation, training materials, and CAPA coordination, leading enterprise PV initiatives and safeguarding patient safety across regions.