Director, PV Clinical Operations

The Director, PV Clinical Operations provides functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials, including study setup and conduct, CRO training, and ongoing vendor management. This role involves partnering with stakeholders within and outside PV to ensure globally harmonized operations, consistent application of PV principles and standards, and effective delivery of critical clinical trial safety activities to support Takeda’s mission.

How you will contribute:

• Conduct risk-based quality reviews of outsourced deliverables, including SAE reconciliation, SAE forms and completion guidelines, protocol safety sections, and eTMF documentation.
• Review and provide PV input into key study documents and safety reporting instructions.
• Maintain direct engagement with vendor PV Operations Leads to monitor performance and identify, escalate, and mitigate study and program level risks.
• Represent PV Operations on global program and study teams to ensure appropriate integration of safety requirements.
• Partner with Clinical Science, Data Management, Regulatory Affairs, and other functions to promote consistent PV standards, processes, and regulatory compliance. Lead or support study- and program-specific audits and regulatory inspections.
• Drive continuous improvement in the collection, processing, documentation, and evaluation of clinical trial safety data.
• Maintain current knowledge of global PV regulations and industry practices while mentoring junior team members.

Skills and qualifications:

• Skilled in clinical trial pharmacovigilance operations, providing functional expertise and oversight of outsourced activities.
• Proficient in risk-based quality reviews of clinical trial safety deliverables and documentation.
• Knowledgeable in global PV regulations and industry practices, supporting consistent application of PV standards.
• Skilled in vendor oversight, proactively identifying and addressing operational risks.
• Experienced in supporting audits and regulatory inspections, including preparation of timely responses.
• Strong critical thinking and analytical skills, with the ability to make high-level decisions in cross-functional and global environments.
• Ability to review, analyze, interpret, and present complex data to a high standard. Strong interpersonal communication skills, working effectively with internal and external stakeholders at all levels.
• Good cross-cultural understanding and experience.
• Excellent organizational skills, prioritizing individual and departmental workloads and managing multiple critical issues simultaneously.
• Demonstrated negotiation and consensus decision making skills.
• Able to mentor junior team members and promote cross-functional awareness of PSPV processes and standards.

As a functional expert within Takeda’s global Pharmacovigilance organization, you possess in-depth expertise in clinical trial PV operations and work effectively across related functions. You’re adept at anticipating cross-therapeutic area risks and process gaps, recommending improvements, and developing practical solutions. Your role involves partnering across functions and with CROs to strengthen operational quality, compliance, and integrated ways of working.