Case Processing Specialist

hace 6 días

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

At Prime Vigilance Ltd, we are seeking a highly skilled Pharmacovigilance Officer to join our team. As a key member of our pharmacovigilance 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.

Key Responsibilities:

  • 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

Why Prime Vigilance Ltd?

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
  • 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 are key to how we operate, and if you feel they resonate with you then Prime Vigilance Ltd could be a great company to join

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

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