Pharmacovigilance Specialist

1 semana atrás


Lisboa, Lisboa, Portugal Jobtome Tempo inteiro

**Job Summary:**

We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Organon. As a key member of our Global Safety Department, you will be responsible for the day-to-day management of adverse event case reports.

Responsibilities:

  1. Manage and coordinate adverse event case intake and follow-up activities in accordance with global pharmacovigilance procedures and country regulations.
  2. Perform case safety report (ICSR) tracking, translation to English, and forwarding of information to the Data Management Center.
  3. Execute local pharmacovigilance processes and activities in alignment with PV systems and their associated Quality Management System.
  4. Reconcile adverse event cases received from local operating units and contractual partners, and process reports in accordance with local procedures and PV legislations.

Requirements:

  • Minimum 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
  • General knowledge of PV regulations within assigned countries and expertise in PV processes/activities.
  • Good communication and time management skills.
  • Health, life science, or medical science degree or equivalent by education/experience, and fluency in English (written and spoken).

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