This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director/Senior Director, Safety-PV Operations Lead based in Italy.
This is a senior pharmacovigilance leadership role responsible for shaping and executing global safety operations across late-stage clinical development and commercialization activities.
You’ll own the operational safety model, ensuring it remains lean, agile, compliant, and capable of supporting complex global programs.
The role combines strategic oversight with hands-on execution, including vendor management, safety documentation, signal management, and regulatory readiness.
You’ll work closely with medical safety, regulatory, quality, biostatistics, medical writing, and external partners to maintain high standards of patient safety and compliance.
The position offers significant influence over safety processes, governance, systems, and operational strategy within a fast-moving biotechnology environment.
You’ll collaborate across North America, Europe, and Israel,



working with distributed teams and external vendors in a highly flexible setting.
This is an opportunity to make a meaningful contribution to global drug development while helping build scalable safety capabilities for future commercialization.
n

Accountabilities:
Provide strategic direction for global safety and pharmacovigilance operations, ensuring an effective, compliant, and cost-efficient operating model.
Develop, maintain, and oversee safety operational documents and agreements with external partners, including Joint Operating Guides, Safety Management Plans, and Safety Data Exchange Agreements.
Coordinate the development of core safety documents, including DSURs, Reference Safety Information within Investigator’s Brochures, CCSI, and RMP/REMS materials, in collaboration with Regulatory Affairs.
Coordinate high-quality safety outputs with Biostatistics, Quality Assurance, medical writing, and external

📌 Director/Senior Director, Safety-PV Operations Lead (Italia)
🏢 Jobgether
📍 Italia