Ergomed
PV Officer, Team Lead (Japanese Fluency required )
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Job Title: ICSR Team Leader
Company Description
PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider, established in 2008. With global organic growth, our team spans Europe, North America, and Asia, delivering tailored services in:
- Medical Information
- Pharmacovigilance
- Regulatory Affairs
- Quality Assurance
We support small to large pharmaceutical and biotechnology partners, fostering long-term relationships to become a global leader in our field. Our expertise extends across all therapy areas, including medical devices.
We prioritise employee investment through:
- Exceptional training and development platforms
- A commitment to well-being, mental health, and work-life balance
- Enabling high-quality client service through a sustainable, supportive environment
Join us to make a positive impact on patients' lives.
Job Description
Leads the team responsible for ICSR management for assigned projects.
Key Responsibilities:
Team and Project Leadership
- Ensures adequate task distribution across assigned projects and teams.
- Oversees end-to-end workflow processes.
- Maintains effective collaboration with clients in ICSR Management.
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Management and Operations
- Provides support to project teams for client and company activities.
- Line-manages assigned ICSR staff.
- Establishes and monitors project-specific KPIs across contracted ICSR activities, optimising procedures, training, and efficiency initiatives.
- Proposes process improvements to the ICSR Operational Lead.
- Manages ICSR deviations, in collaboration with the ICSR Operational Lead.
- Reviews tracker data and timesheets to ensure accuracy.
Subject-Matter Expertise
- Participates in ICSR processing and 2nd QC of cases.
- Acts as the assigned team SME and supports other SMEs.
Requirements
Qualifications
- Life science graduate (pharmacy, nursing, or other healthcare-related qualification/experience).
- Extensive pharmacovigilance experience, including demonstrated leadership in a line management role.
- Must fluent in English and Japanese.
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Key Skills and Competencies
- Exceptional written and verbal communication.
- Strong organisation, attention to detail, and multitasking abilities.
- Effective delegation and planning with time management.
- Technical proficiency in ICSR-related processes.
- Strong team collaboration capabilities.
Why PrimeVigilance?
Our unique company culture ensures:
✅ Diversity, equity, and inclusion as core values. ✅ A human-centric environment fostering growth across cultural backgrounds, genders, and ages.
Surveys & Development
- Training and career growth opportunities.
- Personal and professional development initiatives.
Workplace Culture
- Friendly, supportive working environment.
- Global team access through English as the primary language.
Our Values
We operate with operational integrity based on:
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We’re excited to review your application and welcome you to join our team!
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