Sr. Director, Quality Assurance PV

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers.

Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission.

Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust.

By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other.

Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients.

Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients.

It’s our work, our passion, and our legacy.

We invite you to join us.  

Hybrid

Employee Value Proposition: 

At Taiho Oncology, the compassion we practice for our patients extends to our team, empowering and motivating them to do their best work for those who need it most.

This is an exciting opportunity to support and contribute to the continuous building of a unified Quality Assurance function in a dynamic, collaborative, and global cross-functional environment.

Position Summary: 

The Senior Director of Quality Assurance, Pharmacovigilance (PV) is responsible for partnering with the Leader of Pharmacovigilance to assure their strategy and execution ingrains quality and compliance across all aspects of product safety across clinical development and post-marketing surveillance.

This role is instrumental in applying a risk-based approach to ensure that PV activities align with regulatory requirements and company standards.

Additionally, this position would represent QA to identify risks, resolve issues, and escalates appropriately to ensure the safe use of products globally.

This leader should demonstrate a high level of independent quality judgement and acumen.

In partnership with the Pharmacovigilance (PV) colleagues, drive strategy and execution of the following:


* Establish and maintain a compliant QA oversight program for PV data and ensure compliance with reporting standards and company policies.


* Perform periodic regulatory intelligence on new Health Authority policies and industry standards that impact PV.

Understand and implement changes to maintain compliance.


* Provide Quality Assurance leadership and Subject Matter Expertise (SME) for Good Pharmacovigilance Practices (GVP) to pharmacovigilance teams.


* Provide QA oversight for end-to-end PV activities, including case processing, safety surveillance, risk management, and signal detection and assessment.


* Drive a risk-based approach to PV activities, with appropriate metrics and trending.


* Responsible for insp...