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About the Role

This role defines and implements the local Patient Safety & Pharmacovigilance (PSPV) strategy, ensuring patient safety by providing benefit/risk expertise to cross-functional teams and maintaining a high-quality, compliant PSPV system.

Responsibilities

Define and implement local PSPV strategy for delegated and other products.
Ensure consistent implementation of risk mitigation strategies.
Provide benefit/risk expertise to cross-functional teams.
Lead the preparation of local Risk Management Plans (RMPs) in accordance with Japanese requirements.
Implement global risk minimization measures.
Provide PV input to local labeling documents and educational materials.
Perform local safety data monitoring.
Inform PVWG Chairperson of relevant new safety information.
Promote safety assurance measures, including drug use guidelines.
Perform Medical Quality Review of fatal/life-threatening cases and define follow-up measures.
Complete fatal case investigation reports.
Manage health authority requests, safety issues, and crisis management.
Contribute to the PSPV culture and maintain a high-quality local PSPV system.
Review controlled documents (e.g., PV Working Instructions, SOPs).
Conduct PV trainings for internal and external customers.
Ensure inspection readiness and support management of non-compliance.
Report and contribute to the investigation of non-compliances and CAPA activities.
Support local inspection readiness and participate in PV audits and inspections.
Enhance PV compliance culture and awareness at the local level.
Cooperate with Global PSPV on new regulations and assess local impact.
Contribute to setting up/optimizing local PSPV processes and documentation.

Requirements

Excellent knowledge of applicable global, regional, and local PV regulations, BI processes, and relevant GxP requirements.
Compliance with ethics at all times.
Substantial knowledge about local GVP/GPSP regulation and global GVP regulation.
Experience in pharmacovigilance or safety evaluation activities, including risk management, benefit-risk assessment, periodic reporting, signal evaluation, or related activities.
Experience working in cross-functional teams and managing multiple stakeholders.
Excellent command of English language (TOEIC score more than 785).
Japanese: Native language proficiency.
English speaking CEFR level: B2.

Skills

Proactive and assertive attitude to establish team and networking
Problem-solving skills
Crisis-management skills
Analytical skills on industrial trends
Conceptual and strategic thinking
Project management skills
Decision-making skills
Ability to share knowledge and support team development
Customer service orientation
Excellent communication skills
Excellent presentation skills

Location

Japan

Work Type

Full-time

Experience Level

1+ years of experience in the pharmaceutical industry in a medical department.
Experience as a clinician.

Education Level

Medical doctor degree.
Experience as a clinician.

About the Company

BI (Boehringer Ingelheim)