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• Systematically studied pharmaceutical courses, including Medicinal Chemistry, Pharmacology, Pharmaceutics, etc., laying a solid theoretical foundation for pharmacovigilance work. • Actively participated in pharmaceutical experimental courses organized by the school, improving experimental operation skills and data analysis ability. • During the school period, won scholarships many times, demonstrating good learning ability and academic literacy.
• Responsible for collecting, organizing and analyzing ADR reports to ensure the accuracy and integrity of data. By establishing an efficient data collection process, the collection efficiency of ADR reports was increased by 30%. • Closely cooperated with the R & D, production, sales and other departments within the company, timely communicated ADR-related information, and provided strong support for the safety evaluation of products. Successfully assisted the R & D department to optimize the production processes of 2 drugs, reducing the ADR incidence rate. • Regularly wrote pharmacovigilance reports to report the drug safety situation to the superior leaders and regulatory authorities. The accuracy and timeliness of the reports were unanimously recognized by the company and the regulatory authorities. • Participated in the internal pharmacovigilance training and publicity activities of the company to improve employees' awareness and attention to pharmacovigilance work. Organized 5 internal trainings, and the training coverage rate reached 100%.
• Responsible for establishing and maintaining the company's pharmacovigilance database to ensure the safety and reliability of data. By optimizing the database architecture, the efficiency of data query and analysis was improved, and the average query time was shortened by 50%. • Tracked the updates of domestic and foreign pharmacovigilance regulations and guidelines, and timely adjusted the company's pharmacovigilance strategies and processes. Successfully responded to 3 regulatory changes to ensure that the company's pharmacovigilance work complied with regulatory requirements. • Participated in the pharmacovigilance assessment work of the company's new products and provided safety assessment reports for the listing of new products. Participated in the assessment work of 5 new products, and 3 products were successfully launched. • Maintained good cooperative relations with external pharmacovigilance institutions and experts, and shared pharmacovigilance experience and information. Established cooperative relations with 5 external institutions and jointly carried out 2 pharmacovigilance research projects.
• As the project leader, led the team to complete the pharmacovigilance retrospective analysis project of the company's key products. Through the analysis of a large number of ADR data, discovered the potential safety risks of the products and put forward targeted improvement suggestions. • During the project, formulated a detailed project plan and data analysis plan to ensure the timely completion of the project. Organized many team meetings to coordinate and solve the problems encountered in the project. • In the end, the project results were highly recognized by the company leaders, and the relevant improvement suggestions were incorporated into the subsequent R & D and production plans of the products.
• Participated in the big data research project of pharmacovigilance jointly organized by the company and external institutions. Responsible for data cleaning and preprocessing to ensure that the data quality meets the research requirements. • Using data analysis tools, mined and analyzed massive ADR data, and discovered some new drug safety signals. • The project results were presented at the international pharmacovigilance conference and received attention and praise from industry experts.
• With [X] years of pharmacovigilance work experience, familiar with the work processes of ADR monitoring, data analysis, regulatory compliance, etc. • Have good data analysis ability and problem-solving ability, and can discover potential drug safety risks from massive data. • Have strong communication ability and teamwork spirit, and can effectively communicate and cooperate with relevant departments and institutions inside and outside the company. • Familiar with domestic and foreign pharmacovigilance regulations and guidelines, and can timely adjust the company's pharmacovigilance strategies and processes to ensure that the company's pharmacovigilance work complies with regulatory requirements.
• Participated in the pharmacovigilance training course organized by [Specific Organization], systematically studied the theoretical knowledge and practical skills of pharmacovigilance. • The training content included Adverse Drug Reaction (ADR) monitoring, data analysis, regulatory compliance, etc. Passed the training assessment and obtained the training certificate.