Pharmacovigilance Associate

hace 2 semanas


Madrid, Madrid, España Viatris A tiempo completo
Job Overview

Viatris is a leading healthcare company that empowers people worldwide to live healthier at every stage of life. As a Pharmacovigilance Technician, you will play a key role in maintaining the pharmacovigilance system at the PV Department at the Spanish affiliate.

Key Responsibilities
  • Monitor PV mailbox and other communication channels for incoming ICSRs on drugs and parapharmaceuticals.
  • Perform ICSR management (for drugs, medical devices, cosmetics and food supplements) and CSR reconciliations with applicable stakeholders.
  • Assist in review of PV SOPs and other department's SOPs for alignment.
  • Directly involved in the continuous improvement work with regards to local PV procedures and tools.
  • Actively participate in audits and inspections.
  • Perform local quality and compliance (QC) work.
  • Support Corrective Action and Preventive Action (CAPA) plans and continuous improvement work within the PV area.
  • Assist in Risk Management Plan activities and Direct Healthcare Professional Communications (DHPC).
  • Identify, negotiate and establish the applicable pharmacovigilance agreements.
  • Assist in CEP (Customer Engagement Program) activities.
Requirements
  • Bachelor's degree or equivalent in health science.
  • Prior experience in PV and case processing of minimum 1-2 years.
  • Fluent in Spanish and English (oral and writing), C1 Advanced qualification or equivalent.


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