Senior Specialist or Manager, Pharmacovigilance, Oncology
Core
Leading a team of PV operations to execute day-to-day operations and compliance activities for maintaining high-functioning PV systems across the assigned region remit, specifically for oncology products in Japan.
Role type
Senior Specialist or Manager, Pharmacovigilance (Oncology)
Builds
PV systems, safety reports, risk management plans, and launch strategies for oncology products in Japan.
Domain
Life Sciences / Oncology / Pharmacovigilance
Deliverable
client delivery
Required skills
ICSR management, periodic safety reporting, audit and inspection management, risk management plan development, safety monitoring, protocol review, local regulatory compliance, team leadership, metrics oversight
Preferred skills
None stated
Technologies
None stated
Responsibilities
Record, process, and follow up on adverse events and safety information; perform expedited reporting and local-language literature review; lead preparation of periodic safety reports (J-DSUR, J-PSUR, etc.); manage internal PV audits and regulatory authority inspections; develop and implement Risk Management Plans (RMPs); monitor incoming local safety data for EPPV; ensure launch readiness for new drugs/additional indications; review research protocols from a safety perspective.
Seniority
Senior, hands-on IC with team leadership
