Pharmacovigilance Officer
hace 4 semanas
We are PrimeVigilance, a specialized mid-size pharmacovigilance service provider established in 2008. Our team is dedicated to providing first-class support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in our field. Our Mission is to make a positive impact in patients' lives by delivering high-quality client services. Job Description At PrimeVigilance, we are seeking a Pharmacovigilance Officer to join our team of independent case processing team members. As a PV Officer, you will be responsible for managing a variety of case processing services with full accountability. You will work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. Responsibilities include:
- Processing of Individual Case Safety Reports from all sources in compliance with applicable regulations, PrimeVigilance procedures, and 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)
- Life science/bio-medical background graduate or other healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.)
- Demonstrated experience in case processing