Specialist or Senior Specialist, Pharmacovigilance
Core
Leading a team of PV operations to maintain high-functioning pharmacovigilance systems and ensure compliance with local regulations in Japan.
Role type
Senior Specialist, Pharmacovigilance Operations Lead
Builds
PV systems, safety reports, and compliance frameworks for AbbVie's therapeutic areas in Japan
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
Team leadership, ICSR management, Periodic Safety Reporting (PSUR/DSUR), Audit and Inspection management, Risk Management Plan (RMP) development, Business continuity planning, Safety data monitoring, Protocol review
Preferred skills
Cross-functional collaboration, Strategic planning for drug launches, Training matrix development
Technologies
PV systems, Safety reporting tools
Responsibilities
Lead PV operations team to ensure system performance and regulatory compliance; Develop and maintain local/regional procedures and perform impact assessments; Record, process, and follow up on adverse events (ICSR) and conduct expedited reporting; Lead preparation and submission of periodic safety reports (J-DSUR, J-PSUR); Manage internal audits, third-party audits, and regulatory authority inspections; Develop and implement Risk Management Plans (RMPs) and EPPV strategies; Monitor incoming local safety data and communicate concerns to Safety Science; Ensure successful local regulatory compliance for new drug launches; Establish after-hours reporting processes and business continuity plans; Review research protocols from a safety perspective.
Seniority
Senior, hands-on IC with team leadership