Global Pharmacovigilance Specialist

hace 2 semanas


Madrid, Madrid, España Prime Vigilance Ltd A tiempo completo
Overview

PrimeVigilance Ltd is seeking a highly skilled PV Officer to join our team. As a key member of our case processing team, you will be responsible for managing Individual Case Safety Reports (ICSRs) from various sources, including post-marketing and clinical trials. Your primary goal will be to ensure compliance with applicable regulations, PrimeVigilance procedures, and client-specific requirements.

Responsibilities
  1. ICSR Processing: Process ICSR reports from all sources, including post-marketing and clinical trials, in compliance with applicable regulations and client-specific requirements.
  2. SAE/SUSAR Management: Independently manage SAE/SUSAR reports, including submissions, unblinding, and clinical trial reconciliations.
  3. Database Outputs: Prepare database outputs for periodic reporting, including PBRER, DSUR, and PADER.
  4. Mentoring and Training: Mentor and train new and junior employees within the department, focusing on procedure optimization and development.
Requirements
  • Life science or biomedical background with a healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in pharmacovigilance case processing.
  • Demonstrated case processing experience.
  • Preferred experience with Argus.
  • Strong time and issue management, delegation, organization, and multitasking skills with attention to detail.
  • Advanced English skills, both verbal and written, at least C1 level.
Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders, and ages can contribute and grow. We offer training and career development opportunities internally, a strong emphasis on personal and professional growth, and a friendly, supportive working environment.



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