Job Summary: A Pharmacy Biochemistry professional with experience in pharmacovigilance and team management, to work in drug safety, customer support, and regulatory compliance. Key Highlights: 1. Central role in Pharmacovigilance and Drug Safety 2. Team management in Customer Service (SAC), Pharmacovigilance, and Medical Information 3. Interaction with corporate pharmacovigilance and Latin America Description: * Bachelor's degree in Pharmacy Biochemistry; * Solid experience in customer service, pharmacovigilance activities, and medical information within a pharmaceutical company, including people management responsibilities; * Active registration with the Regional Pharmacy Council. * Availability for 100% on-site work. * Willingness to travel, with up to a minimum of 10% of working time dedicated to travel. * Minimum of 5 years of experience in the field. Responsible for adverse event processing, preparation and review of periodic pharmacovigilance reports, training other departments and service providers, SAC support, compliance reporting, interaction with corporate pharmacovigilance and other Latin American countries. Experience in SAC and pharmacovigilance required. Essential Functions: * Provide support to the multidisciplinary activities of the Drug Safety team and report directly to the Pharmacovigilance Manager. * Ensure appropriate handling of all customers, consumers, healthcare professionals, or others interested in the company's products and services; * Train other Torrent departments and service providers; * Coordinate pharmacovigilance, SAC, and Medical Information activities to ensure compliance with national, international, and contractual requirements for effective reporting of cases to health authorities, headquarters, and other stakeholders; * Responsible for drug safety activities related to both development-stage and commercially registered products under the company’s name; * Supervise interactions with headquarters, other subsidiaries, and partners to resolve product-related issues and adverse event reporting; * Serve as focal point for Regulatory Affairs, Marketing, Medical, and Training departments, clarifying technical questions regarding the company’s products; * Support the review and approval of promotional materials; * Assist in managing the SAC, Pharmacovigilance, and Medical Information teams, interacting with and providing necessary resources (information, knowledge, etc.) to enable team performance and achievement of expected results; * Provide technical support to analysts across these areas; * Support pharmacovigilance representatives before ANVISA and CVS-SP; * Ensure adherence to and compliance with local and international company regulations and standards; * Ensure adherence to and compliance with local and international pharmacovigilance policies and legislation; * Perform other job-related tasks as assigned. Pharmacovigilance Activities: * Monitor and ensure submission of adverse events to Global Pharmacovigilance. * Monitor and ensure Global Pharmacovigilance performs causality assessments. * Monitor and ensure completion and submission of Expedited and Periodic Reports. * Provide safety information to the Medical Department or other departments, as instructed. * Generate customized pharmacovigilance, customer service, market complaint, and other reports as needed for approval. * Manage receipt, tracking, follow-up, and archiving of all serious adverse event (SAE) reports from clinical studies. * Maintain understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global regulations for drugs/biologics/devices, Good Clinical Practices (GCPs), ICH guidelines, and the drug development process. * Acquire basic understanding and maintain knowledge of ongoing projects and disease-related terminology. * Participate in internal and regulatory authority audits; 2512250202491935136
João Silva
Indeed · HR
João Silva
Indeed · HR
