长沙招聘

通过中智签订合同6个月，派至知名美资500强公司上班

工作地：徐汇世纪商贸广场（地铁：1/7号线常熟路站）

备注：

经验：不限，有药物警戒相关工作经验优先，根据工作背景

教育背景：须是医药、生物或护理等相关专业，本科或以上学历

英语能力：书面熟练（工作中涉及大量中英书面翻译工作）

PV Training: NJO, PV training to new hirer, annual refresh training to all Baxter staff, customer facing staff, 3rd party, etc.

AE/SAE Processing

To collect, process and follow up all local adverse events (AEs)/ serious adverse events (SAEs) from different sources (Healthcare professionals, sales and marketing personnel, patients, clinical trials, etc.);

To report the AE/SAE to the Health Authority (HA) according to the Chinese regulation within the required timeframe;

To transmit all reports in English to the GPS organization within the required timeframe;

To archive all source documentation in accordance with Quality Control;

To file all Pharmacovigilance source documents and keep them available upon request by the HA;

Routine interaction with HA, monthly handling feedback cases

Routine case handling; spontaneous cases, literature cases

Hotline handling: pick up 24hrs hotline and hotline case intake

Monthly foreign cases line listings submitted online

To support BQ PV activities related, such as

Regular & ad-hoc safety committee meeting with stakeholders, material preparation.

Safety data provided as request

Safety analysis report preparation

Studies Activities

Working with clinical operation team for SAE reconciliation plan, and perform reconciliation if appropriate

PSURs

Understand China PSUR guidelines

Communicate with GPS safety writing team to draft PSUR following China guidelines

To collect and maintain product registration information and commercial data to be used for PSUR

Prepare the PSUR calendar every year and communicate with GPS medical safety writing team

To submit individual PSUR to HA

Communicate with HA officer to obtain approval of PSUR

Interaction with internal key stakeholders

Internal interaction with manufacturing plant acting as a PV representative for each of the manufacturing plant

Internal interaction with QA/RA/MA/CO for investigation of product safety related issues

External interaction with HA to ensure successful implementation of China PV regulation

Safety Committee Meeting

Work with BQ plant and ADR center

PV system process

Understand China PV regulation and Baxter China business

Work with PV manager to improve PV process / system

Support business projects via ensuring proper PV process are followed

AE reports- Case investigation

Draft death case investigation report

Draft group AE investigation report

Draft case analysis report as appropriate

Perform safety surveillance activities for potential safety signals (e.g. similar AEs reported in a cluster or multiple cases for one batch) and escalate as per procedures

Communicate effectively any safety signals observed to the appropriate management team

Support the label update and license renewal

Review safety section of the label

Draft safety summary for license renewal

Others:

Self-training: TCU, We Comply, external training, etc.

Team meetings and meeting arrangements

Monthly metrics update

Fax, group mailbox, post, etc. daily checking

上海中智项目外包咨询服务有限公司是中智上海全资子公司，发展至今，经与几千家各个行业的企业成功合作，服务网络覆盖全国300多个城市。以服务外包的形式为企业提供“优质、高效、便捷”的灵活用工、项目管理、办公室商务服务等，其中全球500强企业占比超过50%，涉及制造、金融、化工、医药、奢侈品与消费品、进出口贸易等行业，并且与服务客户建立了良好的合作伙伴关系。
中智将以不懈追求卓越的精神，坚持传承与创新，积极探索企业发展的新方向、新路径，推动企业实现新发展，继续强化质量意识，加强质量管理，落实质量责任，提高服务质量，进而为将上海建设成“具有国际竞争力的质量高地”作出更大的贡献。