PV Operations Specialist
7 dni temu
About the Role:
We are seeking a highly motivated and detail-oriented PV Officer to join our team. As a key member of our project team, you will be responsible for processing Individual Case Safety Reports from all sources in compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements and timelines.
Responsibilities include:
- Processing of Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures and in accordance with client specific requirements and timelines.
- Independent SAE/SUSAR Management (submissions, unblinding, clinical trial reconciliations).
- Preparation of database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
- Mentoring and training of new and more junior employees within the department, including procedure optimization and development.
Qualifications:
- Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
- Demonstrated case processing experience.
- Time and issue management, delegation, organization and multitasking skills with good attention to detail.
- Strong interpersonal and communication skills.
- Advanced English skills, both verbal and written, at least C1.
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