PHARMACOVIGILANCE SPECIALIST (Affirmative vacancy for Black and Mixed-race professionals)
Come be part of Daiichi Sankyo, a Japanese pharmaceutical company whose mission is to contribute to improving the quality of life of people around the world through the creation and supply of innovative medicines that meet various medical needs. We have a culture of collaboration and trust and here, we want to develop and grow together. We are an inclusive company that embraces diversity. Everyone is welcome, regardless of sex, ethnicity, religion, sexual orientation, or any type of disability. Here, your talent speaks loudest! For more information on how your data will be treated, access the DSBR Privacy Policy.
Responsibilities and assignments Act as a technical reference in Pharmacovigilance, guiding the team and supporting the resolution of higher complexity themes; Prepare, review, and implement procedures, instructions, forms, and other documents related to Pharmacovigilance processes; Prepare and review regulatory Pharmacovigilance documents, including Risk Management Plans, Periodic Benefit-Risk Evaluation Reports, and risk minimization reports; Conduct and support activities for detection, assessment, monitoring, and documentation of safety signals; Implement and monitor risk management and minimization activities, evaluating their execution and effectiveness when applicable; Evaluate regulatory updates and global procedures, identifying impacts and supporting the implementation of necessary adjustments in local processes; Conduct quality investigations, root cause analyses, CAPAs, risk assessments, and effectiveness checks related to Pharmacovigilance; Perform technical oversight of suppliers, partners, and third parties in the processes under your responsibility, monitoring performance, compliance, and corrective actions; Prepare and review Pharmacovigilance contracts and agreements and evaluate company projects, research, and initiatives regarding applicable requirements; Develop and deliver Pharmacovigilance training and support the technical development of other employees in the area; Prepare and analyze indicators, trends, and compliance information, contributing to the identification of risks and improvement opportunities; Act as a technical reference in the preparation and monitoring of Pharmacovigilance audits and inspections; Interact with headquarters, affiliates, partners, suppliers, internal areas, and sanitary authorities on themes related to the activities under your responsibility; Support the RFV in the maintenance and continuous improvement of the Pharmacovigilance System and act as an escalation point for technical issues; Act as a substitute for the Pharmacovigilance Responsible (RFV), when formally designated, ensuring the continuity of applicable responsibilities during their absence;
Requirements and qualifications Completed higher education in Pharmacy; Advanced English; Intermediate Spanish is desirable; Experience in Pharmacovigilance in the pharmaceutical industry or healthcare area; Solid knowledge of Brazilian regulation, good practices, and main Pharmacovigilance processes;
Experience in activities of higher complexity, including risk management, quality/compliance, regulatory documents, and support for audits and inspections.