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.