Pharmacovigilance Analyst Pl (affirmative vacancy for Black and Mixed-race people)

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 believe that through the inclusion of diverse talents, with different stories, experiences, and opinions, we can strengthen our team and be protagonists in the transformation of society. 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

• Provide support in the preparation or review of Pharmacovigilance training materials;
• Prepare, review, and perform regulatory submissions or the sending of Pharmacovigilance documents to partners (Risk Management Plan, Periodic Benefit-Risk Evaluation Report, Risk Minimization Report); Manage demands and deadlines for Pharmacovigilance reports for regulatory authorities and partners;
• Prepare, review, and keep updated Forms (FORMS), Reference Lists (LRs), Work Instructions (ITPs), and Standard Operating Procedures (SOPs) of the Pharmacovigilance department;
• Interact with the headquarters, other subsidiaries, and partners regarding adverse event reports, database configurations, and Pharmacovigilance reports and plans;
• Conduct training and manage evidence of pharmacovigilance training;
• Provide support in the approval of projects and/or DSBR third-party contracts with responsibility for reporting Pharmacovigilance reports;
• Provide support to regulatory intelligence in Pharmacovigilance, to monitor updates to applicable regulations and impacts on the company;
• Provide support in the translation of package inserts from the DSBR portfolio;
• Provide support in the management of CAPA action plans under the responsibility of the Pharmacovigilance area;
• Provide support in attending Pharmacovigilance audits, when necessary;
• Act as back-up in activities related to the operation;
• Be a back-up to process individual Pharmacovigilance cases in the form and deadlines established for the product, by a standard and/or contract, in the absence of the responsible third parties;
• Propose and contribute to improvement and excellence projects for the department.

Requirements and qualifications

• Higher education in Pharmacy;
• Advanced English;
• Experience in pharmacovigilance activities.