🇬🇧 PV 英文面试预习手册

Good morning. My name is [姓名]. I have three and a half years of experience in pharmacovigilance. I started as a PV specialist managing safety data for high-risk products, such as lidocaine injection. For the past two and a half years, I have served as the PV lead, supporting both R&D-stage products and post-marketing safety management. I have hands-on experience in CDE regulatory interactions, PSUR preparation, safety data analysis, and risk assessment.

早上好，我叫[姓名]。我有三年半的药物警戒工作经验。最初担任 PV 专员，负责利多卡因注射液等高危品种的安全性数据管理；近两年半担任 PV 负责人，同时支持研发期产品和上市后安全管理。我在 CDE 沟通、PSUR 撰写、安全性数据分析和风险评估方面有实际经验。

My main responsibilities include collecting, assessing, and reporting adverse drug reaction information in accordance with regulatory requirements; preparing PSURs and other safety documents; conducting signal detection and risk assessment; and communicating with regulatory authorities.

我的主要职责包括：按法规要求收集、评估和报告不良反应信息；撰写 PSUR 等安全性文件；开展信号检测和风险评估；与监管部门沟通。

I led the response to a CDE deficiency letter for penicillamine. We compared the pharmacokinetics of the two strengths and provided the rationale for discontinuing the 125mg strength, demonstrating bioequivalence and supporting the more flexible 250mg dosage form.

我主导了青霉胺的 CDE 发补回复：比较两种规格的药代动力学，论证 125mg 撤市的理由，证明两规格生物等效，支持更灵活的 250mg 剂型。

For cetirizine hydrochloride injection, the first generic injection of this kind in China, I supported the indication expansion from adults to pediatric patients aged 6 months and above, using foreign clinical data. It was approved after multiple rounds of negotiation with the CDE.

西替利嗪注射液是国内首仿注射剂，我支持了从成人扩展到 6 个月以上儿童的适应症增补，利用国外临床数据，经多轮 CDE 沟通后获批。

When the company planned to extend the indication of ambroxol granules to children aged 2 to 3, I assessed the choking and aspiration risk of the anhydrous formulation and recommended limiting it to ages 4 to 6, which was accepted.

公司想把氨溴索颗粒适应症扩到 2-3 岁儿童，我评估了无水吞服剂的呛咳窒息风险，建议只扩到 4-6 岁，最终被采纳。（这是你独立医学判断的亮点！）

I independently prepared the PSUR for our product, and it passed the regulatory review on the first submission. I believe this was due to both the favorable safety profile of the product and the standardized, well-documented report we prepared.

我独立撰写的 PSUR 一次性通过审评。我把它归因于品种安全性好 + 规范化写作（诚实是加分项）。

I managed the safety data of lidocaine injection, a high-risk product with a large volume of use. We received multiple reports of anaphylactic shock, and all patients were successfully rescued with no fatalities. This experience taught me how to distinguish the inherent safety profile of a product from product quality issues.

我管理利多卡因注射液（集采高用量高危品种），收到多例过敏性休克报告，全部抢救成功、无死亡。这段经历让我学会区分"品种固有安全性特征"和"产品质量缺陷"。

I believe drug safety is the foundation of patient care. Pharmacovigilance combines medical knowledge with regulatory science, and I enjoy using my clinical background to protect patients. I also see great potential in applying AI technology to PV work, which is a direction I am passionate about.

我认为药品安全是患者医疗的基石。药物警戒把医学知识与法规科学结合，我喜欢用我的临床背景保护患者。我也看好 AI 技术在 PV 领域的应用，这是我热爱的方向。

I have three strengths: first, attention to detail, which is essential for case processing and regulatory documents; second, independent medical judgment, for example, my risk assessment on the pediatric indication expansion; and third, hands-on regulatory experience, including direct communication with the CDE.

我的三个优势：一是注重细节（个案处理和法规文件的关键）；二是独立医学判断（如儿科适应症的风险评估）；三是真实的监管沟通经验（直接与 CDE 打交道）。

My current company is undergoing organizational changes, and my position is being affected by factors beyond my control. I am looking for a new opportunity where I can fully apply my PV experience and continue to grow.

我目前公司正在进行组织调整，岗位变动非我本人意愿。我希望在新平台充分发挥我的 PV 经验并继续成长。（委婉、不抱怨、向前看）

My PV experience is mainly in R&D support and post-marketing safety management. For R&D-stage products, I provided safety data analysis and regulatory responses, which is closely related to clinical PV. I understand the core clinical PV processes, including SAE handling, SUSAR reporting timelines, DSUR preparation, and safety management plans, and I am confident I can quickly adapt.

我的 PV 经验主要在研发支持和上市后管理。研发期我做了安全性数据分析和法规回复，与临床 PV 密切相关。我理解临床 PV 的核心流程（SAE 处理、SUSAR 时限、DSUR、SMP），有信心快速适应。（诚实 + 迁移能力）

An adverse event is any untoward medical occurrence in a patient after drug exposure, which does not necessarily have a causal relationship with the treatment. An adverse drug reaction implies a causal relationship — it is a harmful response to a drug used at normal doses.

AE 是用药后出现的任何不良医学事件，不一定与药物有因果关系；ADR 则意味着存在因果关系——正常用法用量下的有害反应。

A serious adverse event includes: death; a life-threatening condition; hospitalization or prolongation of hospitalization; persistent or significant disability or incapacity; congenital anomaly or birth defect; or other medically important events.

严重标准：①死亡 ②危及生命 ③住院或住院时间延长 ④永久或显著残疾 ⑤先天性异常/出生缺陷 ⑥其他重要医学事件。

A SUSAR is a suspected adverse reaction that is serious, unexpected — meaning not consistent with the IB or label — and for which a causal relationship with the study drug cannot be ruled out. Fatal or life-threatening SUSARs must be reported within 7 days, with an additional 8 days for follow-up information; other serious SUSARs within 15 days.

SUSAR = 严重 + 非预期（与 IB/说明书不符）+ 不能排除因果关系。致死/危及生命 7 天内报告（另 8 天提交随访信息）；其他严重 15 天内。

Serious refers to the outcome of the event, such as death or hospitalization. Severe refers to the intensity of the event. For example, a severe headache is intense, but it is not necessarily serious.

Serious 指后果（死亡、住院等），Severe 指程度（强度）。如"剧烈头痛"是 severe，但不一定是 serious。

Unexpected means the adverse reaction is not consistent with the information in the label, package insert, or Investigator's Brochure. It is sometimes called "unlabeled."

Unexpected（非预期）= 与说明书/IB 中的信息不符，也叫 unlabeled（未列明的）。

MedDRA is the Medical Dictionary for Regulatory Activities, a standardized international medical terminology used to code adverse event information for regulatory reporting and analysis.

MedDRA 是国际医学用语词典，用于对不良事件信息进行标准化编码，便于监管报告和分析。

A signal is information suggesting a new potentially causal association, or a new aspect of a known association, between a drug and an adverse event, which requires further investigation and evaluation.

信号 = 提示药品与事件之间可能存在新关联（或已知关联出现新变化）的信息，需要进一步评估。

According to the Chinese GVP, for innovative drugs, PSURs are submitted annually until the first re-registration, and every five years afterwards. Other products are reported every five years.

中国 GVP：创新药每年 1 次直至首次再注册，之后每 5 年；其他品种每 5 年。