Manager Patient Safety Italy
Core
Lead pharmacovigilance activities for the Sandoz affiliate, ensuring local safety procedures are comprehensive, effective, compliant, and embedded in the global-regional-local environment.
Role type
Manager, Pharmacovigilance
Builds
Local safety procedures, safety information management, and regulatory compliance for marketed and investigational products.
Domain
Pharmaceutical industry, Pharmacovigilance
Deliverable
client delivery
Required skills
Medical Doctor or Pharmacist qualification, Italian language proficiency, English language proficiency, drug-safety or pharmacovigilance experience, leadership in patient safety, knowledge of regional/local PV requirements, PV-process knowledge, audit and inspection experience, interdisciplinary team leadership
Preferred skills
Experience in pharmaceutical industry, experience in patient-oriented programs, experience in case handling and periodic report generation
Technologies
PV databases, quality management systems
Responsibilities
Act as National/Local Qualified Person or Local Contact Person for Pharmacovigilance, establish oversight mechanisms for outsourced safety activities, ensure seamless flow of safety relevant information, maintain awareness on safety profiles of Sandoz products, influence the affiliate organization on safety requirements, participate in the maintenance of the local quality management system
Seniority
Manager, local/matrix environment
