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Reporting to: Pharmacovigilance Manager Position description: Responsible for carrying out the PV related work according to ICH-GCP, SOPs, project specific procedures, and applicable regulatory requirements. Responsibilities: ? Support to set up the related system and safety database ? Support the PV related work in the clinical projects including but not limited to: case receipt, case processing, and expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, and the preparation of safety management plan as requested. ? Support to perform post-marketing PV service tasks including but not limited to: case handling, literature searching and reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines. ? Conduct the quality control of pharmacovigilance activities to ensure the data accuracy and completion. ? Ensure the safety reports are delivered to the authority and other stakeholders in a timely manner according to the regulations. ? Provide timely response to the PV related questions to the sponsors and authorities if required. ? Communicate and maintain a good relationship with the internal and external stakeholders, such as the sponsors, investigators and authorities. ? Handle the pharmacovigilance affairs according to the tasks assigned by the country PV officer. ? Support audits/inspections and implement relevant CAPAs if necessary. ? Perform the tasks assigned by line manager. Qualifications: Education and Experience: ? Bachelor of pharmacy/nursing/medicine/biology or a related major. A master degree is preferred. ? 1 year or above PV relevant experience is preferred ? Knowledge of clinical medicine is preferred. Skills and Competencies: ? Ability to quickly learn and master local regulations, ICH related regulations and essential knowledge about therapeutic areas, pharmacovigilance and clinical trial. ? Proficient in the use of computer software such as MS office applications. ? Proficient in the use of safety data base (such as ARISg, ARGUS, CRSCube) are preferred ? Fluent in both written and oral English. ? Good interpersonal skills to professionally communicate with all levels of the organizations. ? Good time management & multi-task capability.