Systems Analyst II, Global Patient Safety, Systems & Analytics jobs in United States
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Revolution Medicines · 12 hours ago

Systems Analyst II, Global Patient Safety, Systems & Analytics

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies. The Systems Analyst II position supports the configuration, maintenance, and continuous improvement of the Global Patient Safety systems, ensuring data quality and operational efficiency across pharmacovigilance processes.

Health CareLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Support system upgrades and ongoing maintenance through the development of system user and functional requirements, qualification scripts, and other validation deliverables
Effectively communicate and coordinate with internal and external stakeholders to gather and implement requirements
Execute routine system configuration updates to support evolving safety processes and business requirements
Maintain user roles, permissions, and access controls in alignment with governance standards
Support system validation activities including documentation, testing, and change‑control processes
Troubleshoot system issues and coordinate resolution with internal teams and external vendors
Assist in the extraction of safety data, ensuring accurate and timely distribution to key stakeholders
Format safety output (line listings, tables, graphs) to support regulatory reporting and business‑partner inquiries
Familiarity with safety dashboards and analytics, including operational metrics, signal detection analyses, and compliance monitoring reports, to support operational insights and decision‑making
Facilitate routine data‑quality checks to ensure accuracy, completeness, and regulatory readiness
Investigate data discrepancies and partner with stakeholders to resolve root causes
Serve as a technical resource for GPS users, providing guidance on system functionality and best practices
Participate in continuous improvement initiatives through innovative technology solutions and process enhancements
Work collaboratively with Safety Operations, Safety Science, and other departments to ensure pharmacovigilance system compliance and best in class operations
Participate in cross‑functional projects involving system enhancements, integrations, and process improvements
Understand integrations between safety systems and upstream/downstream platforms
Document system processes and SOP inputs to support operational consistency and compliance
Support vendor coordination for issue resolution, enhancement requests, and release planning
Assist in the development of safety system training to ensure common understanding of features and functionality, as well as Revolution Medicine’s consistent and proper use of the system
Assist in preparing for global inspections by ensuring all processes and trainings reflect global regulatory requirements
Ensure system activities align with GxP expectations and internal quality standards
Ensure all safety systems and processes comply with global regulatory requirements including FDA, EMA, PMDA, and other relevant authorities
Maintain audit‑ready documentation for configuration changes, testing, and data‑quality activities
Support inspection and audit requests by preparing data outputs, evidence of system validation, and responding to technical inquiries

Qualification

Safety databases experienceData analysis tools proficiencyPharmacovigilance regulations awarenessSQL proficiencySafety reporting systems experienceAnalytical skillsQuality commitmentProblem-solving skillsCommunication skillsCollaboration skills

Required

Bachelor's degree in a scientific, technical, or related field required
At least 2 years in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry regarding pharmacovigilance safety databases, safety reporting systems, and data analysis tools
Hands‑on experience with safety databases and systems (e.g., Safety One Argus, Empirica Signal, Veeva Safety Docs) or similar regulated systems
Proficiency in data tools such as SQL, Spotfire, Oracle Analytics Server, or equivalent
Awareness of global pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH)
Strong analytical, problem-solving, and decision-making skills, with the ability to interpret complex safety data to make informed decisions
Clear and concise communication with technical and non‑technical stakeholders
Ability to manage multiple priorities in a fast‑paced environment
Collaborative mindset with a focus on partnership and service delivery
Commitment to quality and compliance in all system‑related activities
Foster a structured and efficient work environment
Excellent written and verbal communication skills, with the ability to effectively liaise with internal and external stakeholders
Proven ability to think strategically, drive innovation, and implement process improvements

Preferred

Degree in computer science or related field preferred
Working knowledge of pharmacovigilance processes including case processing, ICSR and aggregate reporting, and electronic data exchanges
Experience interacting with regulatory agencies and participating in regulatory inspections and audits

Benefits

Competitive cash compensation
Robust equity awards
Strong benefits
Significant learning and development opportunities

Company

Revolution Medicines

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Revolution Medicines is an innovative and dynamic organization of expert biologists, chemists, pharmacologists, clinical scientists.

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 Company
Total Funding
$2.25B
Key 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

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Luan Wilfong
Chief Human Resources Officer
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Steve Kelsey
President
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Company data provided by crunchbase