Local Safety Officer
Amgen Inc.
Buenos Aires, Argentina
hace 6 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.

Visit : www.amgen.com

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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