Sr. Manager Global Safety Database Configuration

Role Summary

Senior Manager, Global Safety Database Configuration in Cambridge, MA. The role acts as subject matter expert for the safety database, leading administration and code changes, driving digital transformation in pharmacovigilance while maintaining regulatory compliance. The position includes supporting inspections and ensuring operational excellence of PV systems.

Responsibilities

• Serve as technical configuration expert for the PV TechOps team on administration of business changes within the safety database (products, licenses, studies, reporting, codelists, etc.).
• Monitor safety system performance, troubleshoot data discrepancies, system errors, and identify process inefficiencies.
• Manage IT change control, issue identification and appropriate escalation.
• Develop and maintain SDLC documents including requirements, functional specifications, and validation documents.
• Lead E2B program expansion based on business needs and interpretation of global regulatory changes.
• Support MedDRA upgrade and related activities.
• Perform data extraction and analysis using SQL.
• Create SQL DML and DDL scripts to enhance the Safety database to meet evolving business needs.
• Support integration of new data sources and automation initiatives.
• Balance IT standards with business needs to guide informed decisions.
• Strategize and plan PV systems enhancements/projects in support of global business initiatives and regulatory requirements.
• Communicate with regulatory agencies/partners as appropriate.
• Oversee vendor management activities.
• Maintain PV systems compliance with global regulations.
• Provide support to PV Systems regulatory inspections and internal audits.

Qualifications

• Minimum 7 years of pharmaceutical or healthcare-related industry experience.
• Minimum 5 years of experience in Pharmacovigilance.
• Minimum 5 years of experience with safety data, databases, and computerized systems.

Education

• Bachelor’s degree required; Master’s preferred in computer science, information systems, life sciences, or related technical discipline.

Skills

• Ability to handle system support, data management, and reporting independently.
• Proven coding experience with Oracle SQL and Argus Safety database or other safety databases (ARISg, Veeva).
• Proficiency in Python for scripting, data manipulation, and process automation; other automation technologies is preferred.
• Knowledge of data visualization tools (Tableau, Spotfire) is preferred.
• Knowledge of drug safety regulations (ICH, FDA, EMA) and pharmacovigilance data (case processing, MedDRA coding) is desirable.
• Knowledge of data integrity, system validation, and computer system compliance (21 CFR Part 11, EU GVP).
• Experience in matrix management and strengths in teambuilding, motivating and developing people.
• Strong negotiation and consensus decision-making skills.
• Professional interaction across functions and with external partners; ability to represent the department and company.