Senior Director, Pharmacovigilance Operations

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

Job summary

Takeda, in Cambridge, MA, seeks a Director of PV Clinical Operations to provide functional expertise and program oversight of outsourced pharmacovigilance activities across clinical trials.

You will lead risk-based quality reviews, oversee vendor performance, and ensure global PV standards and regulatory compliance across programs, working with Clinical Science, Data Management, Regulatory Affairs, and other functions.

Qualifications

• Experience in clinical trial pharmacovigilance operations and outsourced PV activities.
• Ability to perform risk-based quality reviews of safety deliverables and documentation.
• Knowledge of global PV regulations and industry best practices.
• Experience overseeing vendors and monitoring performance in PV.
• Strong ability to communicate with internal and external stakeholders across functions.

Responsibilities

• Conduct risk-based quality reviews of outsourced PV deliverables including SAE reconciliation and eTMF documentation.
• Review PV input into key study documents and safety reporting instructions.
• Engage with vendor PV leads to monitor performance and mitigate risks.
• Represent PV Operations on global teams to integrate safety requirements.
• Lead or support PV audits and regulatory inspections and promote regulatory compliance.

Skills

PV operations leadership

risk-based reviews

vendor oversight

regulatory compliance

cross-functional collaboration

audits & inspections

data interpretation

Job description

Takeda, in Cambridge, MA, seeks a Director of PV Clinical Operations to provide functional expertise and program oversight of outsourced pharmacovigilance activities across clinical trials.

You will lead risk-based quality reviews, oversee vendor performance, and ensure global PV standards and regulatory compliance across programs, working with Clinical Science, Data Management, Regulatory Affairs, and other functions.