药物警戒PV

该职位来源于猎聘 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.