pv药物警戒专员

1. Execution of all ICSR processing (e.g. ICSR collection, ICSR processing, follow-up) and
reporting is compliant with respective Company procedures:
- Case classification, intake, and local review of Patient Safety relevant information in Global
Safety Platform.
- Coordinates the medical review of incoming case information, where required.
- Ensures high quality translation of the case receiving in local language or in case with
complex information (where feasible within the required timelines).
- Ensures personal information is redacted from source data in line with data protection
requirements.
- Queries concerning case information (=Follow up) are sent out within the valid Company
timelines and properly document in Global Safety Platform.
- Queries are easy to understand for external customers and targeted to the missing
information (e.g. by prepopulating forms/questionnaires with available information).
-ICSR Submission to local Health Authorities and facilitating submission to the Ethic
Committees/Institutional Review Board (IRB) by Clinical Operation Department is performed
in line with Company processes and regulatory requirements.
- Review ICSR related package report (FQTR, LORE, LCPA, DILO, PSUR Interval Line Listing)
within the required timeframe.
-Monitors Health Authorities' comments in HA system.
-Provide feedback to line manager any discovered findings on enhancement of ICSR
processing process.
2. Contributes to the quality of the local PV system by taking over and executing the following
tasks in line with Company processes and timelines, for examples but not limit to:
- Support of local inspections/audits and participation in PV audits and PV inspections as
requested.
- Screens local scientific literature for identification of PV relevant information.
- Assist line manager or function by the set-up/optimizing of local ICSR related processes
including the takeover of subtasks.
- Archiving:
• All relevant documents are independently archived in a timely manner in accordance to
Company processes and regulatory requirements.
• External Archive: Archive retrieval checks are performed independently and timely and are
documented.
3. Collaboration and contribution:
- reporting of non-compliances as soon as become aware of it
- Support the implementation activities to enhance PV compliance culture and PV awareness
at local level of the organization in line with global recommendations
4. Additional accountabilities will be assigned per this position, considering the working
experience and task complexity.
Working Experience:
At least 2 years of PV operation working experience.
Minimum Education/degree requirements:
Pharmacist, nurse, life sciences or other related
Degree / Education: Bachelor’s degree or above, Master preferred
Major / Focus: Pharmacy, Nursing, Biology or other related
Required Capabilities:
- ability to prioritize workload and perform under stress in situations in which working
efficiency and sustained attention are critical aspects of the job
- good technical understanding and experience in working with databases
- ability to converse with other medical professionals to collect, interpret and reconcile
complicated medical data
- good communication / interpersonal and organisational skills
- problem solving skills
- ability to work efficiently in a team
一、工作内容：
1.个例安全报告（ICSR）处理与上报执行：
所有 ICSR 处理（如 ICSR 收集、处理、随访）及上报工作，均严格遵循公司相关流程
2.本地药物警戒（PV）体系质量保障：
依据公司流程与时限要求，承担并执行以下工作，助力提升本地药物警戒体系质量
3.协作与贡献：发现不合规情况立即上报。依据全球指导方针，支持相关落地工作，提升组织本地层面的药物警戒合规文化与意识。
二、任职要求
1.工作经验：至少2 年药物警戒实操工作经验。
2.学历：本科及以上，硕士优先
3.专业：药学、护理学、生物学或相关专业