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Safety Data Analyst
2 tygodni temu
About the Position:
This is an exciting opportunity to join our team as a PV Officer, working on a variety of case processing services with full accountability. You will be responsible for processing Individual Case Safety Reports, managing independent SAE/SUSAR submissions, preparing database outputs, and mentoring and training new employees.
Key Responsibilities:
- Process Individual Case Safety Reports from all sources in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines.
- Manage independent SAE/SUSAR submissions, unblinding, and clinical trial reconciliations.
- Prepare database outputs for periodic reporting.
- Mentor and train new employees within the department.
Requirements:
- Life science or biomedical background with healthcare-related degree and demonstrated experience in Pharmacovigilance case processing.
- Case processing experience.
- Excellent time and issue management, delegation, organization and multitasking skills.
- Strong interpersonal and communication skills.
- Advanced English skills, both verbal and written, at least C1.
