PrimeVigilance
PV Officer, Team Lead
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PV Officer, Team Lead
Team Leader (ICSR Management) – Job Description
Location: Global (remote/hybrid options, انظر قاعدة فعله!) Department: Pharmacovigilance
Company Description
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider founded in 2008. We have achieved organic global growth year-on-year, with staff based across Europe, North America, and Asia. Our team provides first-class support in the following areas:
- Medical Information
- Pharmacovigilance
- Regulatory Affairs
- Quality Assurance (QA)
PrimeVigilance collaborates with small to large pharmaceutical and biotechnology partners, maintaining long-lasting relationships, and has become a global leader in the field. We cover all therapy areas, including medical devices.
Our people-first approach includes investing in staff growth through:
- Excellent training and development programs
- Commitment to employee well-being and mental health
- Emphasis on work-life balance to sustain high-quality client service
Join us in our mission to make a positive impact on patients’ lives.
Role and Responsibilities
The Team Leader (ICSR Management) will:
Team Leadership & Process Oversight
- Lead a team managing Individual Case Safety Reports (ICSRs) for designated projects
- Distribute responsibilities efficiently across projects and teams
- Oversee the workflow process to ensure timely and compliant delivery
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Client Support & Cooperation
- Enhance collaboration with clients in the domain of ICSR management
- Support project team activities on behalf of the client/company
Team & Operational Management
- Line manage assigned ICSR staff
- Create, maintain, and optimize project-specific KPIs for ICSR activities (e.g., training, efficiencies)
- Propose process improvements to the ICSR Operational Lead
- Manage ICSR deviations in collaboration with the ICSR Operational Lead
- Review trackers and timesheet data for accuracy
Technical Engagement & Subject Matter Expertise (SME)
- Participate in ICSR processing (including second-level Quality Control)
- Serve as the assigned Team SME and support other SMEs where required
Requirements
Qualifications & Experience
- Degree in life sciences (preferably pharmacy, nursing, or related healthcare field)
- Extensive experience in pharmacovigilance, with demonstrated leadership in a line management role
- Professional exams (e.g., GCP, pharmacovigilance certifications) are considered advantageous
Core Competencies
✔ Exceptional communication (written and verbal) ✔ Strong organization, attention to detail, and multitasking ✔ Ability to delegate effectively and manage strong teams ✔ Skilled in planning, time management, and technical execution ✔ Adaptability to remote collaboration (English language proficiency is the company standard: interactions may include Japanese speakers in team settings)
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Why Join PrimeVigilance?
Diversity & Workplace Culture
We foster an inclusive, equal-opportunity environment where employees of all cultural backgrounds, genders, and ages thrive. Our company values human-centric growth to ensure collaboration—because our people are our greatest strength.
Our guiding principles reflect our core operations:
✦ Quality – Excellence in every service ✦ Integrity & Trust – Rigorous ethical standards ✦ Drive & Passion – Inspiring company innovation ✦ Agility & Responsiveness – Adaptability to industry shifts ✦ Belonging – A collaborative community ✦ Collaborative Partnerships – Trustful, value-aligned relationships
Benefits & Opportunities
- Training & career development programs
- Commitment to personal and professional growth
- Friendly, supportive work culture
- Work with a global team (colleagues across Europe, North America, and Asia)
- English-as-default corporate language with optional Japanese fluency
Applied candidates, we look forward to your application!
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