Director, PV Clinical Operations

Takeda•Cambridge, MA

5d•$177,000 - $278,080

About The Position

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. The role partners with stakeholders within and outside Pharmacovigilance to support globally harmonized operations, consistent application of PV principles and standards, and effective delivery of clinical trial safety activities. As a functional expert in Takeda’s global Pharmacovigilance organization, the Director applies in-depth expertise in clinical trial PV operations and works across related functions. The role anticipates cross-therapeutic-area risks and process gaps, recommends improvements, and develops practical solutions in partnership with internal functions and CROs to strengthen operational quality, compliance, and integrated ways of working.

Requirements

Expertise in clinical trial pharmacovigilance operations, including functional expertise and oversight of outsourced activities.
Proficiency in risk-based quality reviews of clinical trial safety deliverables and documentation.
Knowledge of global PV regulations and industry practices, supporting consistent application of PV standards.
Skill in vendor oversight and proactively identifying and addressing operational risks.
Experience 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 and ability to work effectively with internal and external stakeholders at all levels.
Good cross-cultural understanding and experience.
Excellent organizational skills, including prioritizing individual and departmental workloads and managing multiple critical issues simultaneously.
Demonstrated negotiation and consensus decision-making skills.
Ability to mentor junior team members and promote cross-functional awareness of PSPV processes and standards.

Responsibilities

Conduct risk-based quality reviews of outsourced deliverables, including SAE reconciliation, SAE forms and completion guidelines, protocol safety sections, and eTMF documentation.
Review key study documents and provide PV input, including on safety reporting instructions.
Engage directly 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.
Mentor junior team members and promote cross-functional awareness of PSPV processes and standards.
Anticipate cross-therapeutic-area risks and process gaps, recommend improvements, and develop practical solutions with cross-functional partners and CROs.