Director, PV Clinical Operations
About The Position
The Director, PV Clinical Operations provides functional expertise and program-level oversight of outsourced pharmacovigilance activities across clinical trials. This includes study setup and conduct, CRO training, and ongoing vendor management. The role partners with stakeholders within and outside PV to support globally harmonized operations, consistent application of PV principles and standards, and effective delivery of clinical trial safety activities. As a functional expert within 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.
- Experience in vendor oversight, including proactively identifying and addressing operational risks.
- Experience supporting audits and regulatory inspections, including preparing 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 work effectively across related functions and with CROs.
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 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
