職位描述
工作職責(zé):
SOP
? Support line manager to review, update and set up local procedure, make sure SOPs& WI reflect current local procedure.
Training
? Provide training to company staffs during orientation and/or cycle meeting/annual meeting.
? Ensure training content compliance with external partners and company requirements.
Audit
? Ensure compliance in routine job.
? Ensure CAPA process is in place to manage any non-conformity.
AE/PC Reporting& Data Reconciliation
? Collect, process and follow up all AEs/complaints from different sources (Healthcare professional, sales and marketing personnel, etc.).
? Report AEs/ADRs to external partners within specified timeline in accordance with PV agreements.
? Ensure the local tracking system is in place to guarantee timely submissions of adverse events to external partners and Health Authority.
? Answer the safety questions from the HCP/Health Authority with the support of external partners.
? Conduct timely literature review and report to external partners.
? Submit reports to Health Authority as request.
? Data reconciliation with internal team and external partners.
Clinical Study Activities
? Assist line manager to set up the company PV system for clinical study, ensure all the safety related activities meet the health authority requirements.
? Assist line manager to review protocols, IBs and all safety sections of clinical and/or regulatory submission documents.
? Cooperate with vendor on collection and submission of SAE/Pregnant events to external partners and HA according to the local regulations requirement.
任職資格:
? Bachelor or higher degree with medical or pharmacological background.
? Appropriate experience in pharmacovigilance.
? Fluent in English both in oral & Written.
? Knowledge of China and international safety regulations and guidelines.
? Good communication (oral and written English) skills, ability to liaise with different functions involved: MA, QA, RA and external partners, etc.
