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