Title: Drug Safety and Pharmacovigilance Systems and Analytics Lead
Location: Waltham, MA (Hybrid Opportunity (3 Days/Week On-Site))
Reports Into: Director, Systems & Analytics

The Global Safety System Analyst role is critical for supporting, analyzing, and optimizing pharmacovigilance and drug safety systems. The candidate will leverage Oracle SQL, Snowflake, Python, Tableau, and Spotfire expertise to ensure robust data management, analysis, visualization, and reporting. This position will contribute to enhancing the organization's ability to monitor and analyze data from various sources, such as internal drug safety data, safety data from regulatory agencies, clinical data, etc.

Responsibilities

• Develop software development life cycle (SDLC) documents including as requirement specifications, functional specifications, and validation documentation.
• Develop and maintain data sets and queries using Oracle SQL and Snowflake to support pharmacovigilance and safety reporting needs.
• Perform data extraction, transformation, and analysis using Python to support safety surveillance and regulatory compliance.
• Design and deliver interactive dashboards and visualizations in Tableau and Spotfire to communicate safety trends, signal detection, and compliance metrics to stakeholders.
• Develop and execute user acceptance test scripts to ensure system functionality aligns with business requirements.
• Collaborate with pharmacovigilance, epidemiology, and clinical teams to understand safety data requirements and ensure timely and accurate reporting.
• Monitor the performance of safety systems, troubleshoot data discrepancies, system errors, and identify process inefficiencies.
• Support the integration of new data sources, automation initiatives, and continuous improvement of safety analytics platforms.
• Provides an effective balance between IT standards and strategies with business needs to guide well-informed decisions.

 

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, or a related field required.
• Five years of experience in the pharmaceutical or life sciences industry.
• Ability to handle system support, data management, and reporting independently.
• Proven experience with Oracle SQL and Snowflake in a healthcare, life sciences, or pharmaceutical environment is required.
• Proficiency in Python for scripting, data manipulation, and process automation.
• Advanced knowledge of Tableau and/or Spotfire for building dashboards and data visualization solutions.
• Knowledge of drug safety regulations (e.g., ICH, FDA, EMA guidelines) and pharmacovigilance data (e.g., case processing, MedDRA coding) is highly desirable.
• Strong analytical, problem-solving, and communication skills with the ability to present complex data in a clear and actionable format.

Posted On: Tuesday, July 22, 2025