Country Safety Head, Japan
Core
Ensure local operating company safety activities for products comply with regulations and manage pharmacovigilance, cosmetovigilance, and medical device vigilance in Japan.
Role type
Country Safety Head (Pharmacovigilance)
Builds
Safety reporting systems and compliance processes for medicines, cosmetics, and medical devices
Domain
Healthcare / Consumer Health Products
Deliverable
client delivery
Required skills
Pharmacovigilance management, vendor oversight, regulatory compliance, risk management, audit leadership, CAPA development, business continuity planning, translation of safety documents
Preferred skills
Line management experience, knowledge of global/regional/local procedures, IT safety systems proficiency
Technologies
IT safety systems
Responsibilities
Act as Local Nominated Person for Pharmacovigilance/Cosmetovigilance/Medical Device Vigilance; oversee PV system and vendor resources; manage safety reporting (AE, SAE, SUSARs, PBRER, DSUR, PSUR, RMP); lead health authority inspections and audits; ensure regulatory compliance and implement CAPAs; manage business continuity plans
Seniority
Senior, hands-on IC with line management responsibilities
