November 13, 2024

Galderma

City

OTHER

Mexico Pharmacovigilance Coordinator (CDMX, Mexico)

Con un legado único en dermatología y décadas de innovación de vanguardia, Galderma es el líder emergente en la categoría de dermatología, presente en aproximadamente 90 países. Ofrecemos un portafolio innovador basado en la ciencia de marcas emblemáticas premium y servicios que abarcan todo el espectro del mercado de la dermatología en rápido crecimiento a través de Estética Inyectable, Cuidado Dermatológico y Dermatología Terapéutica. Desde nuestra fundación en 1981, hemos dedicado nuestra atención y pasión al órgano más grande del cuerpo humano, la piel, satisfaciendo las necesidades individuales de consumidores y pacientes con resultados superiores en asociación con profesionales de la salud. Porque entendemos que la piel en la que vivimos moldea nuestras vidas, estamos avanzando en dermatología para cada historia de piel.

Buscamos personas que se centren en obtener resultados, abracen el aprendizaje y traigan una energía positiva. Deben combinar la iniciativa con un sentido de trabajo en equipo y colaboración. Sobre todo, deben estar apasionados por hacer algo significativo para los consumidores, pacientes y profesionales de la salud a quienes servimos todos los días. Nuestro objetivo es empoderar a cada empleado y promover su crecimiento personal mientras se asegura de que se satisfagan las necesidades comerciales ahora y en el futuro. En toda nuestra empresa, valoramos la diversidad y respetamos la dignidad, la privacidad y los derechos personales de cada empleado.

En Galderma, damos activamente a nuestros equipos razones para creer en nuestra ambiciosa meta de convertirnos en la principal empresa de dermatología del mundo. Con nosotros, tienes la oportunidad definitiva de adquirir nuevas y desafiantes experiencias laborales y crear un impacto directo sin igual.

About Galderma

Galderma is the leading company dedicated to dermatology, present in approximately 90 countries. We provide an innovative, science-based portfolio of premium brands and services that cover the full spectrum of the rapidly growing dermatology market through Injectable Aesthetics, Dermocosmetics, and Therapeutic Dermatology. Since our founding in 1981, we have dedicated our focus and passion to the largest organ of the human body – the skin – meeting the individual needs of consumers and patients with superior outcomes in partnership with healthcare professionals. We are advancing dermatology for every skin story because we understand that the skin we are in shapes our life stories.

Working at Galderma

At Galderma, you will have the ultimate opportunity to gain transformative work experiences. We are committed to meeting the individual needs of consumers and patients, with superior outcomes, in partnership with healthcare professionals.

In our company, we embrace differences and respect the diversity, privacy, and personal rights of each employee. We are committed to maintaining a respectful and inclusive workplace. We take pride in our dedication to diversity and inclusion and want to ensure that the people we do business with know, share, and respect our standards.

If you seek to put your ideas into practice, make a difference, and fulfill your purpose, your place is here.

Opportunity – Key Responsibilities

What you will do:

Core Objective:

This position will be directly reported to Lat Am PV Coordinator.

Mexico Scope: Act as local representative (Local Safety Officer - LSO) for drugs, medical devices and cosmetics on behalf of Galderma Mexico with Cofepris (Mexico Health Authority).

Lat Am Scope: Triage, process, elaborate, regulatory submission, review and operationalize processes and procedures related to Galderma Latin America post-marketing surveillance and clinical trial (if applicable), aiming at excellence and segment of current legislation and global processes.

Responsabilities:

Ensure quality management of all procedures, implementation of the audit findings and Pharmacovigilance improvement projects in Latin America, participating in the constant mapping of the implemented processes and review control of the documents.
Assist that any request from the Health Authorities regarding safety information necessary to assess risk-benefit for Galderma products, being available 24/7, in order to send complete answer and in accordance with regulatory deadlines in current legislation.
Operate the vigilance routine actions of Galderma Latin America post-marketing surveillance, through review and submit to Global Pharmacovigilance (Corporate) the adverse event reports, in order to ensure the compliance with national, regional, global, legal and contractual rules.
Implement, elaborate, review and approve the procedures related to Latin America Pharmacovigilance and keep them updated, through periodic search of pharmacovigilance regulations of Latin American and global procedures, aiming the notifications quality of adverse events with Galderma products in accordance with current legislation and related good practice guides.
Review and ensure the implementation of pharmacovigilance training post-marketing Surveillance to all employees of Galderma, through periodic Pharmacovigilance actions according to the presential and conference call/web meeting scheduled trainings, in order that all employees of Galderma America Latin be able to identify and report any adverse events related to Galderma products.
Elaborate and review the documentation for periodic Pharmacovigilance reports (PBRERs and specific safety informs required by Cofepris for drugs and devices), Pharmacovigilance Plan and Risk Minimization Plan, when necessary, in order to ensure the monitoring of Galderma products safety profile.
Notify and review the spontaneous reports of drug adverse events to all Health Authorities in Latin America with Galderma Affiliate, through an electronic form on the regulatory agency website, in order to comply the current legislation.
Ensure that all files related to the Pharmacovigilance and Customer Service areas will be manage following Good Practice of Pharmacovigilance through periodic and continuous document reviews, in order to guarantee traceability according to the current legislation.
Participate in meetings with national entities, public authorities, organizations and associations of Pharmacovigilance and Customer Service, aiming alignment with market actions and anticipation of regulatory and legal needs.
Elaborate and control of compliance metrics in Pharmacovigilance, through KPIs management, aiming the improvement of quality processes.
Support the execution of corporate audits at Galderma Affiliates in Latin America Countries and execute audits at Distributors under LATAM Regional responsibilities, aiming ensure the Good Pharmacovigilance Practices.

Profile:
Academic Background: Professional education in health with experience in Pharmacovigilance.
Intermediate-Advanced English

Advanced-Native language Spanish

Work Experience:

Professional education in the area of health with experience in Pharmacovigilance
Work Experience: over 5 years in Pharmacovigilance

Employer’s Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.