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Pharmacovigilance Temporary Nuevo Grafton España calendar_month hace 2 horas place Barcelona , [...]

PMFarma

Global PV Associate, in charge of Data Surveillance across all company inline medicinal products, medical device and cosmetic products.The PVA Data Surveillance will assume activities required to meet vigilance needs for products within the Rx, Ax, and Cx portfolios for post‑marketing surveillance activities, and regulatory submissions.

Key Responsibilities

  • Routine PV activities to ensure compliance with global vigilance requirements, including ICSR management, QC activities and reporting
  • Oversight of external PV vendor(s) responsible for ICSR management
  • Ensure management of incoming communication to Global PV
  • Support technology activities (PV databases and tools and safety data corrections) as Subject Matter Expert
  • Ensure or support preparation of department quality documents and process improvements

Ideal Profile

  • Pharmacist, Scientist in life sciences
  • Minimum 2 years of experience in a pharmacovigilance role (with an emphasis on ICSR management activities) at headquarters/global level or local level
  • Experience and knowledge of post‑marketing vigilance regulations and industry best practice for medicinal products, medical devices and/or cosmetics.
  • Experience in interactions with various stakeholders, including PV vendors, affiliates and partners
  • Fluent in English, written and oral
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Oferta de empleo publicada 4 días atrás
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