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