Senior Director, Pharmacovigilance Quality and Compliance

Day One Biopharmaceuticals•Brisbane, CA

24d•$270,000 - $300,000•Remote

About The Position

At Day One, we are focused on advancing first- or best-in-class medicines for childhood and adult diseases with equal intensity. We were founded to address the lack of new therapies resulting from the traditional drug development model, that has left children with cancer and their families waiting too long for new, life-changing treatments. Our aim is to accelerate better, targeted treatments so patients of any age can look forward from ‘day one’ to the future they’ve envisioned. POSITION SUMMARY: The Senior Director, Pharmacovigilance Quality and Compliance leads the development, implementation, and oversight of drug safety and pharmacovigilance quality systems to ensure compliance with global regulatory requirements and industry best practices. This role is responsible for maintaining high standards in safety data management, risk assessment, and continuous process improvement across all drug safety operations. For the ideal candidate, location in either Headquarters in San Francisco or the greater Boston area is strongly preferred, for the appropriate candidate and/or role, a remote location may be considered, however increased travel may be required in this instance.

Requirements

Bachelor’s or advanced degree in life sciences, pharmacy, medicine, or related field
12+ years of experience in pharmacovigilance, drug safety, or pharmaceutical quality, with leadership experience preferred.
Extensive knowledge of quality standards, global regulatory requirements (e.g. FDA, ICH, EMA), and industry best practices related to product safety
Demonstrated experience in developing and managing safety programs, conducting/supporting audits, and ensuring regulatory compliance.
Strong analytical, training, and documentation skills, including experience with root cause analysis
Risk assessment / risk management skills
Process improvement and change management experience
SOP development and management
Training program development and delivery
Ability to work independently, provide strategic direction, and collaborate effectively with senior management and cross-functional teams.
Ability to adapt to fast-paced, changing environments and prioritize effectively

Responsibilities

Develops, implements, and maintains quality management systems for drug safety and pharmacovigilance activities, including SOPs, guidelines, controlled documentation, and training programs.
Oversees pharmacovigilance compliance activities, including audits, inspections, deviation management, CAPA (Corrective and Preventive Actions), and root cause analyses.
Advises on pharmacovigilance quality, ensuring adherence to global regulations (FDA, EMA, ICH, GVP, MHRA) and industry standards.
Defines, tracks, and reports key metrics and performance indices to measure the effectiveness of pharmacovigilance quality programs and training.
Monitors and analyzes safety data to identify trends, potential risks, and areas for improvement; leads risk management and mitigation strategies.
Designs and implements comprehensive training strategies for pharmacovigilance staff, cross-functional teams, and vendors, ensuring ongoing compliance and competency .
Leads preparation for regulatory inspections and audits.
Acts as the main point of contact for QA during audits, including response formulation.
Leads corrective action plans related to drug safety and quality assurance.
Identifies gaps in pharmacovigilance systems/processes and drives continuous improvement initiatives.
Collaborates with internal and external stakeholders, including clinical, regulatory, and quality teams, to ensure integrated safety processes and documentation.
Stays current with evolving global regulations and best practices in drug safety and quality management.
Manages and mentors drug safety and quality staff; fosters a culture of continuous improvement and compliance.
Collaborates with Safety Systems to manage and implement change control procedures.