Revolution Medicines · 8 hours ago
Associate Director, Global Patient Safety Quality and Compliance - Pharmacovigilance
Redwood City, California, United States
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$186K/yr - $233K/yr
7+ years expRevolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The Associate Director of Global Patient Safety Quality and Compliance is responsible for overseeing the pharmacovigilance quality management system, ensuring compliance with global regulations, and fostering a culture of safety within the organization.
Health CareLife ScienceMedical
Responsibilities
In cooperation with the GPS leadership team, co-develop and implement the global pharmacovigilance quality management system strategy in alignment with the company’s mission and objectives
Develop and implement a PV training strategy that ensures compliance and ensures high quality and consistent performance
Coach GPS staff ensuring high quality compliance support following best practices, global regulations, and internal requirements
Support the management of the resourcing, budget, and management of pharmacovigilance contract research organizations (PV CROs) in quality and compliance activities
Author and contribute to the preparation of controlled documentation required by health authorities for management of the QMS
Develop and maintain relationships across Revolution Medicines, particularly in Clinical Operations, Clinical Development, Clinical Data Science, Regulatory Affairs, Quality Assurance, Medical Affairs, and other departments as appropriate to ensure a globally compliant QMS
Collaborate to create robust processes to maintain compliance with safety requirements related to safety science processes
Work with the EU Qualified Person Responsible for Pharmacovigilance (EU-QPPV) to ensure European compliance as applicable
Support GPS management in ensuring inspection readiness for global inspections by ensuring all processes and training reflect global regulatory requirements
Manage all inspections that include PV and ensure completion and tracking of CAPAs
Foster a culture of safety, compliance, and continuous improvement within the pharmacovigilance function and broadly across the organization
Ensure compliance with global pharmacovigilance regulations and standards, including FDA, EMA, PMDA, ICH, and other relevant regulatory bodies
Support the GPS response to regulatory inquiries and inspections related to pharmacovigilance inspections
Support the development and maintenance of a pharmacovigilance quality system in line with global regulations (i.e. GCP, GVP) enabling demonstration of quality, effectiveness, and control
Partner with pharmacovigilance systems personnel in the development and implementation of advanced safety data analytics in support the PV-QMS
Contribute to a high-performing global pharmacovigilance team
Promote continuous professional development and ensure the team is equipped with the latest knowledge and skills in pharmacovigilance
Provide regular updates to senior leadership on the status of pharmacovigilance system effectiveness, and regulatory compliance
Ensure clear and effective communication of safety information to internal and external stakeholders
Qualification
Required
RN or Bachelor's degree in biological sciences or health related field required
Minimum of 7+ years of experience in pharmacovigilance or related field within the pharmaceutical or biotechnology industry
Minimum of 4+ years of project management experience; willingness to help others, and ability to deal with ambiguity
Proven track record of accomplishments in global pharmacovigilance environments
Experience and success in interacting with Regulatory Authorities (i.e. FDA, EMA)
In-depth knowledge of global pharmacovigilance regulations and guidelines (i.e. ICH, GxP)
Strong analytical and strategic thinking, problem-solving, and decision-making skills
Excellent communication, collaboration, and team management abilities, enabling exertion of strong and successful influence of senior executives as well as strong external representation for the company
Demonstrated technical expertise in QA/QC
Outstanding emotional intelligence
Proven ability to work collaboratively
Preferred
Advanced degree in Pharmacy, or a related field (PharmD, PhD: preferred)
Experience with development of PV-QMS and key operating metrics enabling demonstration of operational control
Demonstrated ability to manage complex projects and work effectively in a matrixed organization
Proficiency in managing regulatory inspections and interactions
Strong organizational and time management skills, with the ability to prioritize and manage multiple tasks effectively
Excellent influence and collaboration/teamwork capabilities
Benefits
Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities
Company
Revolution Medicines
Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.
501-1000 employees
H1B Sponsorship
Revolution Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (18)
2023 (15)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.25BKey Investors
Royalty PharmaBoxer CapitalNextech Invest
2025-06-24Post Ipo Debt· $250M
2024-12-02Post Ipo Equity· $750M
2023-03-02Post Ipo Equity· $323.6M
Leadership Team
Luan Wilfong
Chief Human Resources Officer
Steve Kelsey
President
Recent News
Pharmaceutical Technology
2026-01-13
Company data provided by crunchbase