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PV Officer, Team Lead
Lead Team Manager – ICSR Management
Company Description
PrimeVigilance, part of Ergomed Group, is a specialised mid-size pharmacovigilance service provider established in 2008. We thrive on global organic growth, with staff across Europe, North America, and Asia, supporting Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
As one of the global leaders in pharmacovigilance for pharmaceutical and biotechnology partners, we cover all therapy areas, including medical devices. We foster long-lasting client relationships while investing in staff training, development, and well-being—prioritising a healthy work-life balance to ensure high-quality service delivery.
Join us in making a positive impact on patients' lives.
Role Overview
As Team Leader (ICSR Management), you will lead and oversee a team responsible for individual case safety report (ICSR) management for specific or multiple projects, ensuring efficient workflow, client collaboration, and team performance.
Key Responsibilities
- Lead and manage ICSR workflow for assigned projects, including optimal task distribution.
- Guarantee effective cooperation with clients in ICSR management operations.
- Support project teams in activities performed on behalf of the company and client.
- Line manage ICSR staff and foster team productivity.
- Develop and maintain project-specific KPIs—optimising procedures, trainings, and actions to improve efficiency.
- Propose process changes to the ICSR Operational Lead.
- Assist and escalate ICSR deviations in collaboration with the ICSR Operational Lead.
- Review trackers and timesheet data for accuracy.
- Actively participate in ICSR processing and 2nd level QA (Quality Control) reviews.
- Serve as the team’s Subject Matter Expert (SME) in ICSR processes, while also supporting other specialists.
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Qualifications & Experience
Education & Qualifications
- Life science graduate, pharmacy, nursing, or other healthcare-related background.
- Alternative experience in pharmacovigilance may suffice.
Experience & Competence
- Extensive professional experience in pharmacovigilance, including experience as a line manager.
- Strong communication skills (written and verbal).
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Soft Skills
- Excellent organisation, multitasking, and attention to detail.
- Effective delegation and planning/time management abilities.
- Proven teamworking skills.
Technical Proficiency
- Fluency in English and Japanese.
Why Join PrimeVigilance?
Organization Value Proposition
We are committed to diversity, equity, and inclusion, creating an equal-opportunity, human-centric workplace where all employees are encouraged to contribute and grow. Our success is driven by a human-first approach, and our people remain our greatest competitive strength.
Employee Benefits
✔ Training and career development opportunities. ✔ Emphasis on personal and professional growth. ✔ A friendly, supportive, and collaborative working environment. ✔ Ability to work with a global team, communicating in English as the company’s primary language.
Core Values
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
Are you aligned with our mission? We look forward to your application!
Department: ICSR Management
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