PV Specialist

2 meses atrás


Lisboa, Lisboa, Portugal Organón Tempo inteiro
Job Description

At Organón, we are seeking a highly skilled PV Specialist to join our team.

Responsibilities

  • Manage and track adverse event cases in accordance with global pharmacovigilance procedures and country regulations.
  • Process individual case safety reports (ICSRs) and perform reconciliation activities.
  • Execute local PV processes and activities in alignment with PV systems and quality management systems.
  • Support Patient Support Programs and/or Market Research vendor(s) related activities.
  • File, store, and archive safety-related and regulatory data and documentation.
  • Act in full compliance with global and local SOPs and report any deviations or compliance concerns.

Requirements

  • A minimum of 1 year of industry experience in pharmacovigilance and/or regulatory affairs.
  • A general knowledge of PV regulations within the assigned country.
  • Excellent communication and time management skills.


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