Senior Director, Pharmacovigilance Quality and Compliance
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior Director overseeing pharmacovigilance quality and compliance for drug safety at Day One Biopharmaceuticals. Leading development and implementation of quality management systems across global regulations.
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.
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.
Similar Jobs
Global Regulatory Lead, PDx
Global Regulatory Lead overseeing pharmaceutical diagnostics from pre-clinical to registration in global markets. Leading regulatory strategy for new product introductions and compliance obligations.
Manager, Regulatory Compliance
Manager of Regulatory Compliance leading U.S. sportsbook trading operations at DraftKings. Ensuring compliance across jurisdictions and managing a team in a fast-paced environment.
Risk and Compliance Manager – Retail Broking
Risk and Compliance Manager supporting compliance obligations for retail broking businesses in the UK. Providing regulatory guidance while working closely with the Risk & Compliance team remotely.
Regulatory Lead – Mount Nansen Remediation
Regulatory Lead overseeing environmental assessments and permitting for Mount Nansen Remediation project. Leading collaboration between technical teams and regulatory bodies.
Regulatory Affairs Associate
Regulatory Affairs Associate for Parexel developing and publishing regulatory submissions to health authorities. Collaborating with stakeholders to ensure compliance and quality in documentation.
IT Compliance Specialist, SISP
IT Compliance Specialist advancing IT Compliance program at Sedgwick. Conducting risk assessments, collaborating with stakeholders, and ensuring regulatory compliance.
Associate Director – Global Compliance Platform
Associate Director overseeing Amgen's global compliance platform (C3) for healthcare compliance requirements. Leading strategy, governance, and operations to optimize compliance processes globally.
Trade Compliance Specialist
Trade Compliance Specialist reviewing and ensuring compliance of export orders and documentation for corporate clients. Collaborating with partners to maintain regulatory standards and documentation accuracy.
Medicare Compliance, Advertising Filing Specialist
Medicare Compliance & Advertising Filing Specialist managing all Medicare advertising submissions through HPMS. Ensuring compliance with CMS guidelines and managing material submissions across multiple carriers.
Senior Director – Contracts Compliance & Operations
Senior Director overseeing the contract compliance program and operational functions at Amentum. Lead initiatives to enhance efficiency and ensure adherence to government regulations.
Senior Director, Global Trade Compliance
Senior Director leading global trade compliance programs and teams at Beckman Coulter Diagnostics. Driving strategy and operational efficiency in a dynamic global business environment with compliance expertise.
Senior Compliance Officer
Senior Compliance Officer overseeing financial services compliance at Acorns. Leading regulatory strategies and ensuring adherence to regulations for a financial wellness platform.
Credentialing & Compliance Lead
Credentialing & Compliance Lead responsible for the Medicare DMEPOS credentialing lifecycle and compliance activities. Facilitating customer interactions and maintaining regulatory standards within a fast-growing startup.
BESS Product Compliance Engineer
Software Solutions Engineer focusing on deploying VaultOS Power Plant Controller in Australia. Collaborating with global teams to develop utility-scale energy storage systems.
Data Protection, Compliance & Transformation Specialist
Referent für Datenschutz, Compliance und Transformation bei Linimed Gruppe GmbH. Verantwortung für operative Umsetzung und Weiterentwicklung der Prozesse im digitalen Bereich.
Business License Compliance Manager
Business License Compliance Manager at Apex Companies ensuring compliance with business licensing across jurisdictions. Overseeing licensing processes, renewals, and regulatory requirements with internal stakeholders.
Manager, Insurance Compliance
Manager, Insurance Compliance responsible for insurance compliance with GSE and HUD lenders. Utilizing a compliance automation platform for efficient portfolio management and strategic client support.
Insurance Compliance Analyst
Analyst handling insurance compliance operations within technology-driven environment supporting GSE and HUD lender portfolios. Collaborating with senior team members for high-quality delivery and improvement.
Compliance Analyst, Research Compliance
Compliance Analyst coordinating export control compliance operations at City of Hope. Ensuring adherence to federal international compliance laws and regulations in the research sector.
Senior Compliance Analyst, Research Compliance
Senior Compliance Analyst at City of Hope ensuring compliance in research activities and regulatory standards. Conducting audits, documenting findings, and assisting in investigations of non-compliance issues.