长沙招聘

工作职责:

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.

任职资格:

? 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.

    我们是中国领先的综合医药公司。我们的愿景是凭借我们经市场验证的完整价值链能力，成为专注于抗感染、心血管疾病及呼吸系统三个核心治疗领域“放眼全球、服务中国”的领先医药公司。

    一方面，我们致力于不断引入全球优质医药资源，拥有世界级生产设施和全球供应链，采用国际标准的运营管理，且领导团队具备国际视野；另一方面，经过近二十年的不断探索，我们凭借对中国市场的深刻洞见，构建起规模化的高效商业化平台和高标准的本土生产基地，并取得卓越的运营表现。

    我们相信“放眼全球、服务中国”的双轮驱动模式，能帮助我们更好地服务中国市场，为患者持续提供优质的全球医疗产品和服务。