药物警戒PV（沈阳）

该职位来源于猎聘 Reporting To

Pharmacovigilance Manager Position Description Responsible for carrying out pharmacovigilance (PV) activities in compliance with ICH-GCP, SOPs, project-specific procedures, applicable regulatory requirements, and Japanese PV regulations where applicable.

Responsibilities Support the setup and maintenance of PV-related systems and safety databases. Support PV activities in clinical projects, including but not limited to case receipt, case processing, safety data review, and expedited/periodic safety reporting to regulatory authorities, investigators, IRBs/ECs, and sponsors. Support the preparation and maintenance of Safety Management Plans and other PV-related documents as required. Support post-marketing PV activities, including but not limited to adverse event case handling, literature surveillance, safety data review, and expedited/periodic reporting in compliance with regulatory requirements and timelines. Handle and review safety information originating from Japanese sources when applicable. Support safety reporting activities for Japanese studies/products and ensure compliance with relevant Japanese regulatory requirements. Conduct quality control of pharmacovigilance activities to ensure data accuracy, consistency, and completeness. Ensure safety reports are submitted to regulatory authorities and other stakeholders within required timelines. Respond to PV-related inquiries from sponsors, regulatory authorities, and other stakeholders in a timely manner. Communicate and maintain effective working relationships with internal and external stakeholders, including sponsors, investigators, vendors, and regulatory authorities. Handle pharmacovigilance activities as assigned by the Country PV Officer. Support audits and inspections and implement CAPAs when required. Perform other duties assigned by the line manager.

Qualifications Education and Experience Bachelor's degree or above in Pharmacy, Nursing, Medicine, Biology, Life Sciences, or a related discipline. Master's degree is preferred. Experience supporting Japanese projects or handling Japanese PV activities is an advantage. Knowledge of clinical medicine is preferred.

Skills and Competencies Business-level proficiency in Japanese and English, both written and spoken. JLPT N1 or N2 is preferred. Familiarity with Japanese pharmacovigilance regulations and safety GUS, ARISg, CRSCube, or similar systems is preferred. Strong attention to detail and commitment to data quality. Good interpersonal and communication skills. Strong time management skills with the ability to manage multiple priorities simultaneously.