Pharmacovigilance Analyst II

Opportunity – Key Responsibilities

• 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.  
• Review and ensure the implementation of pharmacovigilance training post-marketing Surveillance to all employees of Galderma Brazil, Latin America LSOs and Regional PV Staff, 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.  
• Collaborating with activities related to periodic Pharmacovigilance reports, 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.  

Education

• Completed Graduation in the area of health with experience in Pharmacovigilance;
• Verbal and written communication skills;
• Relationship, problem-solving & negotiating skills;
• Fluent in Portuguese;
• Intermediate/advanced in English;
• Basic/intermediate in Spanish;
• Conduct of Pharmacovigilance legislation, Technovigilance and Cosmetovigilance.