Accountability:
一、Collection, report and management of individual safety events and QC
1. To complete the English ICSR of the responsible products and report it to API PV (Group Company's Department of Pharmacovigilance)/business partners within the specified timeline.
2. To report safety events to the drug regulatory authority in accordance with provisions of laws and regulations.
3. To follow up adverse events by telephone etc. according to the requirements of API PV/business partners.
4. To implement ICSR files archiving related work.
5. To implement QC confirmation and related management of ICSR produced by other PV specialists in accordance with the SOP requirements.
二、Overseas Adverse Event Reporting
1. To regularly collate the list of overseas adverse events provided by API PV and translate it into a list that meets the requirements of Chinese laws and regulations;
2. To regularly collate the list of overseas adverse events provided by partners and translate it into a list that meets the requirements of China;
3. To report to national authorities within the time limit.
三、PV document production and training, and data translation
1. To draft or modify departmental WPD documents, implement document training for WPD-related personnel, maintain training records, and supervise the effectiveness of the implementation.
2. To translate PV-SOP, PSUR, AE summary report, PV agreement and other data as scheduled in a timely manner.
四、PV work related with product registration and updates
1. To assist the supervisor in preparation of AE summary of the responsible product, the review of the updated contents of the product labeling, and collation and report of relevant data of clinical trials.
五、PV training management and publicity
1. Under the guidance of supervisor, to implement the production of PV training materials, and training records collation and archiving following the SOP requirements.
2. According to the publicity and education plan, to complete designing, producing and arranging exhibitions of publicity materials and the related work.
六、Monthly Compliance Report production and communication
1. To assist the supervisor in the production of Monthly Compliance Report and communication with API. If necessary, make a CAPA plan and follow up to confirm the improvement results.
七、External customer consultation and related information processing
1. To answer and reply to PV/QA related reports/inquiries/complaints from the call center and internal staff.
2. To make the Chinese information report form and transfer it to the relevant person in charge and obtain a reply.
3. To produce and update FAQ under the guidance of PV medical consultants, and use it flexibly and archive timely.
4. To search and confirm the company's CC system daily, and timely find and process information related with drug safety and product quality.
八、Other
1. To receive necessary drug safety training and assessments to understand the latest news and knowledge of drug safety.
2. To complete other tasks assigned by the PV manager.
Qualifications:
一、Education
1. Bachelor degree or above in pharmacy, pharmacology or clinical medicine related majors.
二、Skills
1. Fluent English speaking and writing (required skills).
2. To understand drug safety related laws and regulations correctly.
3. Good learning, execution, problem analysis and solving abilities.
4. Good communication willingness and ability; ability to communicate effectively by telephone and in writing.
5. Ability to work carefully and seriously to ensure the accuracy and completeness of the information conveyed.
6. Good computer application skills
三、Experience
1. More than 1 year work experience in drug safety.