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Pharmacovigilence Associate - Portuguese Speaking, Remote

icon briefcase Tipo de Emprego : Periodo Integral
icon remote-alt Remote / Work from Home

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Descrição do Emprego - Pharmacovigilence Associate - Portuguese Speaking, Remote

Luminary Group is currently seeking a highly motivated and detail-oriented Pharmacovigilance Associate who is fluent in Portuguese to join our team. This position offers the opportunity to work 100% remotely. As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety and efficacy of our client's pharmaceutical products.

Responsibilities:

  • Review and evaluate adverse event reports and other safety-related information for our client's products.
  • Perform case processing activities, including data entry, coding, narrative writing, and quality checks.
  • Conduct signal detection activities and contribute to the preparation of signal evaluation reports.
  • Collaborate with cross-functional teams to ensure timely and accurate reporting of adverse events to regulatory authorities.
  • Participate in the development and implementation of Pharmacovigilance processes and procedures.
  • Assist in the training and mentoring of junior team members.
  • Maintain knowledge of current regulatory requirements and guidelines related to Pharmacovigilance.
  • Ensure compliance with company policies and standard operating procedures.
  • Contribute to the continuous improvement of Pharmacovigilance activities and systems.
  • Fluency in Portuguese and English, both written and spoken.
  • Minimum of 2 years of experience in Pharmacovigilance or a related field.
  • Strong knowledge of Pharmacovigilance practices and regulations.
  • Experience with case processing activities, including data entry, coding, and narrative writing.
  • Proficiency in using Pharmacovigilance databases and safety reporting systems.
  • Ability to work independently and prioritize tasks effectively.
  • Excellent attention to detail and accuracy in data entry and documentation.
  • Strong analytical and problem-solving skills.
  • Good interpersonal and communication skills, with the ability to effectively collaborate with cross-functional teams.
  • Experience with MedDRA coding and EudraVigilance is desirable.
  • Flexible to work in different time zones, if required.
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