Senior Specialist or Manager, Pharmacovigilance, Oncology
Core
Leading a team of PV operations to maintain high-functioning Pharmacovigilance systems and ensure compliance with local regulations in Japan for oncology products.
Role type
Senior Specialist or Manager, Pharmacovigilance
Builds
PV systems and safety reporting infrastructure for oncology products in Japan
Domain
Healthcare / Pharmacovigilance / Oncology
Required skills
ICSR management, Periodic Safety Reporting (PSUR/DSUR), Audit and Inspection management, Risk Management Plan (RMP) development, Safety data monitoring, Regulatory protocol review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Record, process, and follow up on adverse events (ICSRs); Lead preparation of periodic safety reports (J-DSUR, J-PSUR); Manage internal PV audits and regulatory authority inspections; Develop and monitor Risk Management Plans (RMPs); Ensure launch readiness for new drugs/additional indications; Review research protocols from a safety perspective
Seniority
Senior, hands-on IC