Senior Director, Pharmacovigilance Quality and Compliance
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $270,000 - $300,000 per year
Job Level
About the role
- 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.
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.
Benefits
- Please visit https://www.dayonebio.com/benefits to see our competitive benefits.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancedrug safetyquality management systemsSOP developmentroot cause analysisrisk assessmentrisk managementtraining program developmentauditsregulatory compliance
Soft Skills
analytical skillstraining skillsdocumentation skillsstrategic directioncollaborationleadershipindependenceadaptabilityprioritizationcontinuous improvement