Senior Specialist or Manager, Pharmacovigilance, Oncology
Core
Leading a team of PV operations to execute day-to-day operations and compliance activities for pharmacovigilance systems in Japan, ensuring oversight of performance and functioning in compliance with local regulations.
Role type
Senior Specialist or Manager, Pharmacovigilance (Oncology)
Builds
High-functioning PV systems and safety reporting infrastructure for assigned therapeutic area 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 data monitoring, regulatory protocol review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Record, process, and conduct follow-up on adverse events and safety information; prepare periodic safety reports (J-DSUR, J-PSUR, etc.); manage internal PV audits and regulatory authority inspections; develop knowledge of Risk Management Plans; monitor incoming local safety data; review research protocols from a safety perspective
Seniority
Senior, hands-on IC or Manager