Pharmacovigilance Officer

hace 3 semanas

Madrid, Madrid, España Primevigilance A tiempo completo
Job Description

At PrimeVigilance, we are seeking a highly skilled 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.

Key Responsibilities:
  • Case Processing: Process Individual Case Safety Reports from all sources (post-marketing and clinical trials, including device and combination products) in compliance with applicable regulations, PrimeVigilance procedures, and in accordance with client-specific requirements and timelines.
  • SAE/SUSAR Management: Independently manage SAE/SUSAR submissions, unblinding, clinical trial reconciliations.
  • Database Outputs: Prepare database outputs for periodic reporting (PBRER, DSUR, PADER, etc.).
  • Mentoring and Training: Mentor and train new and more junior employees within the department, including procedure optimization and development.
Qualifications:
  • Life Science/Bio Medical Background: Healthcare-related degree (chemistry, biology, biotechnology, veterinary science) and demonstrated experience in Pharmacovigilance case processing.
  • Case Processing Experience: Demonstrated case processing experience; ARGUS experience preferred.
  • Time and Issue Management: Time and issue management, delegation, organization, and multitasking skills with good attention to detail.
  • Interpersonal and Communication Skills: Strong interpersonal and communication skills.
  • Language Skills: Advanced English skills, both verbal and written, at least C1.
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. To succeed, we must work together with a human-first approach.

Our Core Values:
  • Quality: We strive for excellence in everything we do.
  • Integrity & Trust: We operate with integrity and trust, building strong relationships with our clients and colleagues.
  • Drive & Passion: We are driven by a passion for delivering high-quality results.
  • Agility & Responsiveness: We are agile and responsive, adapting to changing circumstances and priorities.
  • Belonging: We foster a sense of belonging, where everyone feels valued and respected.
  • Collaborative Partnerships: We build strong, collaborative partnerships with our clients and colleagues.

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