Encargado de Registros y Farmacovigilancia at Abbott

Santiago, Santiago Metropolitan Region, Chile

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Profesional Químico Farmacéutico, Médico Veterinario o Bioquímico
Experiencia en la industria Farmacéutica
Manejo del inglés en un nivel básico hablado y escrito
Manejo de Office intermedio y SAP

Responsibilities

Planear, coordinar y controlar los registros internacionales para presentación a la autoridad
Gestionar los plazos para cumplir con las fechas de lanzamiento de nuevos productos acorde al plan comercial
Coordinación y preparación de la información que se presenta en los expedientes de registro
Preparación y presentación de solicitudes de registro e informes de rutina/renovaciones para actualizar la información del producto registrado
Revisar y preparar respuestas a las consultas procedentes de las autoridades reguladoras referidas a los registros de los productos
Preparar y presentar al SAG la documentación de Farmacovigilancia acorde a lo establecido por el Sistema de Farmacovigilancia FAV aprobado por SAG
Presentar documentación a la autoridad sanitaria
Preparar, mantener y presentar la documentación del Sistema de Gestión de Calidad de FAV
Gestionar OC, AT y facturas relacionadas a actividades del área regulatoria

Skills

Pharmacovigilance

Regulatory Affairs

Sanitary Registrations

Project Coordination

Deadline Management

International Regulatory Submissions

Compliance

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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