Associate Director, Safety Systems

## Job Description# Associate Director, Safety Systems* Manage Safety Systems user access, configuration updates, testing, and documentation.* Lead validation, process improvements, and system enhancements.* Develop and maintain SOPs, work instructions, and PV documentation.* Design queries/reports in PV Reports to support aggregate, periodic, and ad hoc reporting.* Configure and maintain electronic gateways, E2B profiles, and troubleshoot transmission issues.* Collaborate with PV Operations, Regulatory Affairs, and Quality Assurance to ensure compliance with global safety reporting guidelines.* Support audits, inspections, and vendor oversight as a subject matter expert.* Provide technical/data management support to ensure accuracy and consistency of safety data.* Train junior staff and vendors on safety system responsibilities.* Contribute to business continuity planning and corrective/preventive action initiatives.* 10–12 years of relevant experience in Safety Systems; Bachelor’s or advanced degree in life sciences, nursing, pharmacy, or related healthcare field.* Expert knowledge of Argus Safety and RxLogix PV Reports; experience with other PV systems (Aris Global, Veeva, etc.) preferred.* Strong technical expertise with proven ability to lead projects and deliver results.* Knowledge of relational databases, SQL, and data migrations.* Solid understanding of GCP/GVP regulations (FDA, EMA, ICH E2B).* Familiarity with PSMF documentation and audit readiness requirements.* Excellent communication, influencing, and negotiation skills.* Highly organized, detail‑oriented, and able to manage multiple projects under tight timelines.* Prior experience with safety database configuration, validation, and upgrades strongly preferred. #J-18808-Ljbffr