Local Safety Officer
Amgen Inc
Buenos Aires, Argentina
hace 7 días

AMGEN is one of the world’s leading biotechnology companies in the pharma industry. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

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Local Safety Officer -Senior Associate

Work Location : Olivos (zona norte GBA)

MAIN RESPONSABILITIES :

  • Timely submission of all reportable adverse event reports, according to Company requirements and local regulations.
  • Timely and accurate capture, routing, translation and follow-up of adverse events reported for inclusion in the Global Safety Database
  • Review, distribution and submission of Periodic Safety Reports and Risk Management Plans
  • Provide training of adverse event reporting obligations to local customer-facing staff and others required by national practice and Company policy, also for relevant contractors, agents, business partners or distributors.
  • Assists with the implementation tracking of risk minimization activities
  • Performs safety screening of local medical literature
  • Review and execute activities as per Pharmacovigilance and / or contract agreements with partners, contractors / vendors and distributors, as applicable
  • Ensures local quality assurance measures to maintain inspection readiness of local safety function.
  • Main Point of Contact for audits and inspections and other PV interactions with local regulators.
  • MANDATORY REQUIREMENTS :

  • Bachelor s degree in pharmacy, biochemistry or biology
  • Minimum experience of 5 years in pharmacovigilance with BIOLOGICAL products
  • Solid knowledge of the requirements and local regulation
  • Experience in review of risk minimization plans
  • Management of databases, operational activities of safety and medical terminology
  • Experience in Quality is a plus
  • Fluent English
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