Systems Analyst II, Global Patient Safety, Systems & Analytics

The Opportunity:

We are seeking a skilled safety systems analyst to join our dynamic Global Patient Safety (GPS) department.  The Systems Analyst II position supports the configuration, maintenance, and continuous improvement of the GPS systems and related technologies. This role serves as a key contributor in ensuring data quality, system reliability, and operational efficiency across pharmacovigilance processes.

The Systems Analyst II collaborates closely with cross‑functional partners, vendors, and internal GPS stakeholders to troubleshoot issues, extract and format data, execute configuration updates, and support enhancements that enable scalable, inspection‑ready safety operations.

The successful candidate will be a proactive, detail oriented, team player who exhibits technical proficiency with best-in-class pharmacovigilance systems. The candidate will meet the following requirements:

System Configuration & Administration

• 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.

Data Quality & Reporting Support

• 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.

Operational Support & Collaboration

• 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.

Compliance & Inspection Readiness

• 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.

Required Skills, Experience and Education:

• 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).

Core Competencies

• 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 Skills:

• 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. 

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