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Pharmacovigilance Coordinator - São Paulo, Brasil - Galderma
Descrição
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Location : CDMX, Mexico.
Objective :
Act as LSO in the country where they are located i.e., management of safety information from various sources, including Healthcare professionals, literature, health authorities and interactions with Regional Head of PV and Global PV teams. Support submission of PV cases and periodic reports to health authorities (e.g., MX Cofepris).
Act as the focal point for Local Safety Officers (LSOs) in Latin American Spanish countries (Argentina, Chile, Colombia, and Mexico) coordinating PV activities in the region and supporting business initiatives and distributors in the Spanish speaking Latam countries.
Ensure compliance to local regulations and coordinate with other functions cross-functional activities.
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, and direct line of communication with the responsible by Pharmacovigilance of Europe (EU-QPPV), aiming the continuity of compliance with Latin America regulations, local, regional and international legislations and global pharmacovigilance policies.
• Ensure 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.
Profile :
: Professional education health with experience in Pharmacovigilance.
Intermediate - Advanced English
Between 3 and 5 years in Pharmacovigilance
Experience in Pharmacovigilance, Technovigilance (device) and cosmetovigilance legislation in Latin America.
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.
