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At Excelya, we embody Audacity, Care, and Energy in all that we do. We offer a dynamic and inclusive environment where innovation and collaboration drive success.
About the Role
The Medical Reviewer provides medical and operational oversight of global pharmacovigilance review activities, ensuring high-quality assessment of ICSRs, compliance with regulatory requirements, and submission readiness for critical cases. The role also supports the continuous improvement and consistency of medical review processes, maintaining alignment with internal quality standards and global regulations.
Main Responsibilities
- Perform medical review of ICSRs ensuring completeness and submission readiness
- Manage complex/high-priority cases with appropriate clinical assessment
- Ensure data quality and consistency in the safety database
- Conduct targeted QC activities and drive corrective/improvement actions
- Lead follow-up activities with internal teams, HCPs, and vendors
- Oversee coding standards (MedDRA, WHO Drug) and ensure global consistency
- Contribute to PV standards, training, and continuous improvement
- Support benefit-risk evaluation and safety strategy activities
- Act as SME for audits and inspections
- Manage processes, vendors, and KPIs, driving operational performance
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Requirements
- PhD or Medical Degree (MD)
- 6-8 years' experience in pharmacovigilance/drug safety
- Strong background in ICSR medical review and PV regulations (clinical & post-marketing)
- Experience in ICSR management, reporting, literature surveillance, and safety data systems
- Knowledge of aggregate safety data analysis and reporting
- Working knowledge of MedDRA and WHO Drug coding standards
- Experience in operational oversight, cross-functional collaboration, and vendor management (preferred)
- Strong communication skills with ability to explain complex topics to diverse audiences
- Proactive, problem-solving mindset with focus on continuous improvement
- Strong analytical, risk assessment, and project management skills, with ability to work independently
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Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique—
- We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience.
- Our one-stop provider service model — offering full-service, functional service provider, and consulting — enables you to evolve through diverse projects.
- Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
- Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
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