Position Overview
A global healthcare and life sciences organization is seeking a Pharmacovigilance Project Manager to oversee project management activities within the Pharmacovigilance (PV) function. This role is responsible for managing drug safety operations across both clinical trial and post-marketing surveillance activities while ensuring compliance with global and local regulatory standards.
Salary
• Annual salary: JPY 7,000,000 – 12,000,000
• Compensation includes estimated bonus components
• Final offer will be determined based on experience, skills, and current compensation
• This position is classified as managerial/supervisory; overtime pay is not provided
• Additional performance bonuses may be paid annually based on company performance
Main Responsibilities
• Lead project management activities related to pharmacovigilance and drug safety information management for clinical and post-marketing projects
• Collaborate with Team Managers to oversee project timelines, quality, profitability, budgeting, and client communications
• Manage daily resource coordination including staffing, budgeting, risk management, and escalation handling while ensuring compliance with GVP/GCP standards
• Establish and oversee safety management frameworks during study start-up activities, including:
• Budget estimation and validation
• Workforce planning
• Preparation of required documentation
• Safety database setup within project timelines
• Support audits and inspections conducted by clients, internal teams, and regulatory authorities
• Drive process optimization, standardization, and continuous improvement initiatives using KPI-based management approaches
• Facilitate regular meetings with clients and stakeholders and lead issue resolution discussions and negotiations
• Coordinate and negotiate with internal departments, regulatory authorities, and external partners
• Collaborate with global teams and partner organizations to ensure alignment with international processes and standards
• Propose and implement operational efficiency improvements using standardized workflows and IT tools
• Provide technical guidance, mentoring, and support to junior team members
• Contribute proactively to organizational development and broader business initiatives beyond assigned projects
Requirements
• Business-level proficiency in both Japanese and English (written and verbal)
• Ability to conduct meetings and negotiations in English with clients and global stakeholders
• Leadership experience within the Pharmacovigilance department of a CRO or pharmaceutical company
• Strong understanding of end-to-end drug safety information management processes for both clinical and marketed products, including:
• ICSR intake
• Triage
• Data entry
• Quality control
• Reporting to regulatory authorities such as PMDA
• Practical experience in budget estimation and cost management
Preferred Profile
• Strong stakeholder management and communication skills
• Experience managing cross-functional and global projects
• Ability to work in a highly regulated environment while maintaining operational efficiency
• Leadership mindset with strong problem-solving and continuous improvement capabilities