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Pharmacovigilance Officer

hace 2 meses

Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo

**Job Summary**

At Prime Vigilance Ltd, we are seeking a highly motivated and detail-oriented Pharmacovigilance Officer to join our team. As a key member of our case processing team, you will be responsible for managing a variety of case processing services with full accountability.

**Responsibilities**

  • Process Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, Prime Vigilance Ltd procedures, and in accordance with client-specific requirements and timelines.
  • Manage SAE/SUSAR submissions, unblinding, clinical trial reconciliations, and prepare database outputs for periodic reporting (PBRER, DSUR, PADER, etc).
  • Work as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of Prime Vigilance Ltd.
  • Reach and maintain a high level of performance within 3 months of being assigned to an ICSR team, following onboarding completion.

**Requirements**

  • Life science/bio-medical background graduate or other healthcare-related degree qualification (chemistry, biology, biotechnology, veterinary science, etc.).
  • Demonstrated experience in case processing.

**What We Offer**

As a Pharmacovigilance Officer at Prime Vigilance Ltd, you can expect to work with teams of different sizes, from small clinical trials to large, generic post-marketing teams. We value employee experience, well-being, and mental health and acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.