Senior Director, Pharmacovigilance Quality and Compliance

SENIOR DIRECTOR, PHARMACOVIGILANCE QUALITY AND COMPLIANCE

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.

ESSENTIAL DUTIES AND 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.

People:

• Manages and mentors drug safety and quality staff; fosters a culture of continuous improvement and compliance.

Systems:

• Collaborates with Safety Systems to manage and implement change control procedures.

QUALIFICATIONS

• 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

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.

INTERVIEW INTEGRITY

At Day One, we expect each candidate to engage authentically, representing their true qualifications and experiences. As part of our screening process, we will conduct several interviews and background verification. This ensures candidates have the skills they claim and align with our values. We are excited to learn more about you and to create a genuine experience for everyone.

COMPENSATION AND BENEFITS

The salary range for this position is $270,000 - $300,000. Day One considers a range of factors when determining base compensation. These considerations mean actual compensation will vary.

Please visit https://www.dayonebio.com/benefits to see our competitive benefits.

DISCLAIMER

Day One Biopharmaceuticals is committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law.

We are unable to sponsor or take over sponsorship of any applicant work visas at this time.

Recruitment & Staffing Agencies: Day One Biopharmaceuticals does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Day One Biopharmaceuticals or its employees is strictly prohibited unless contacted directly by Day One Biopharmaceutical’s internal HR team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Day One Biopharmaceuticals, and Day One Biopharmaceuticals will not owe any referral or other fees with respect thereto.