Position: Case Processing Manager (Pharmacovigilance), Team Lead
Location: Europe (Remote/Hybrid)
Employment Type: Full-time
Department: ICSR Management
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider operating since 2008. We offer first-class medical information, pharmacovigilance, regulatory affairs, and quality assurance services to pharmaceutical and biotech companies worldwide.
With a global presence across Europe, North America, and Asia, we are committed to fostering long-lasting client relationships and maintaining industry leadership in pharmacovigilance.
At PrimeVigilance, we prioritize employee experience, well-being, and career development, ensuring a healthy work-life balance that fosters high-quality client service and meaningful contributions to patient safety.
We are seeking a Case Processing Manager (Pharmacovigilance), Team Lead to oversee ICSR (Individual Case Safety Reports) management for assigned projects. This role involves leading a team, ensuring compliance, optimizing workflows, and maintaining strong client relationships.
The ideal candidate will have strong pharmacovigilance experience, previous line management exposure, and excellent communication and organizational skills.
This position reports to the ICSR Operational Lead and offers a remote or hybrid work model within Europe.
✅ Lead the ICSR management team for designated projects.
✅ Ensure effective task distribution and oversee workflow efficiency.
✅ Line manage and mentor assigned ICSR staff.
✅ Provide guidance, training, and performance support to the team.
✅ Foster strong collaboration within internal teams and with clients.
✅ Oversee ICSR processing and quality control (2nd QC review).
✅ Maintain project-specific KPIs, ensuring optimal efficiency and adherence to regulatory standards.
✅ Identify areas for process improvement and propose changes to the ICSR Operational Lead.
✅ Ensure accurate tracking and timesheet data management.
✅ Manage ICSR deviations with support from the ICSR Operational Lead.
✅ Build and maintain effective client relationships within the ICSR management scope.
✅ Contribute to company goals, objectives, and compliance requirements.
✅ Support cross-departmental activities as needed.
✔️ Educational Background: Degree in Life Sciences, Pharmacy, Nursing, or other healthcare-related fields.
✔️ Pharmacovigilance Experience: Strong prior experience in pharmacovigilance (PV), preferably in a CRO environment.
✔️ Leadership Experience: Previous experience in a line management role.
✔️ Communication & Organization: Excellent written and verbal communication, attention to detail, and multitasking skills.
✔️ Technical & Process Expertise:
🌍 Global Impact: Contribute to patient safety and regulatory excellence worldwide.
📈 Career Growth: Ongoing training and professional development opportunities.
🤝 Inclusive Culture: A diverse, equitable, and supportive work environment.
💡 Innovation & Collaboration: Work alongside colleagues from various countries and backgrounds.
⚖️ Work-Life Balance: Flexible remote/hybrid options to support well-being.
At PrimeVigilance, we believe that our people are our greatest strength, and we foster an environment based on quality, trust, agility, collaboration, and belonging.
Ready to make a difference in global pharmacovigilance?
Apply today and be part of our journey to enhance patient safety worldwide!
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