Pharmacovigilance Specialist

4 semanas atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro
Job Description

Job Title: Pharmacovigilance Specialist

Job Summary:

We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. As a key member of our Pharmacovigilance department, you will be responsible for ensuring the safe and effective use of our products.

Responsibilities:

  1. Manage adverse event cases from receipt to closure in accordance with Global Pharmacovigilance procedures and country regulations.
  2. Perform ICSR intake, tracking, and translation activities.
  3. Execute local PV processes and activities in alignment with PV systems and their associated Quality Management System.
  4. Reconcile PV cases received from local operating units and contractual partners.
  5. Provide support for Patient Support Programs and/or Market Research vendor-related activities.
  6. File, store, and archive safety-related and regulatory data and documentation in accordance with department and company policies.
  7. Act in full compliance with global and local SOPs and report any deviations or compliance concerns immediately.

Requirements:

  • Fluency in Spanish and Portuguese.
  • Ability to work in a team environment.
  • Strong communication and problem-solving skills.
  • Ability to maintain confidentiality and handle sensitive information.

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