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Case Processing Specialist

hace 2 meses

Madrid Centro, Madrid, España Prime Vigilance Ltd A tiempo completo
Job Description

At Prime Vigilance Ltd, we are seeking a highly skilled and motivated 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.

The successful candidate will have a strong background in life sciences or a related field, with demonstrated experience in case processing. You will be working as part of a project team, performing and supporting contracted pharmacovigilance activities on behalf of Prime Vigilance Ltd.

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, Prime Vigilance Ltd 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

Requirements

  • Life science / bio medical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing
  • Demonstrated case processing experience
  • ARGUS experience preferred
  • 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

What We Offer

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly, supportive working environment
  • Opportunity to work with colleagues based all over the world, with English as the company language

Our Core Values

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging