In memory of Xu Ji, a "Safety Guardian" in the Drug Vigilance Department

In the pharmaceutical industry, there is a group of unsung heroes: they do not directly interact with patients, but they are always guarding the safety of every drug; they do not stand in the spotlight of research and innovation, but use their expertise and rigor to build the last line of defense for drug safety. Xu Ji from the Drug Vigilance Department is an outstanding representative of them. Since joining the company seven years ago, she has adhered to the original intention of "patients first" and the principle of "compliance-based", writing an extraordinary chapter of "drug safety guardian" in an ordinary position, and injecting a solid foundation for the company's high-quality development with quarterly hardcore performance.

1. Establishing a Foundation with Professionalism: "Authoritative Recognition" Demonstrates Corporate Responsibility

"Drug vigilance is not a simple report statistic, but to capture the clues of risk from massive data and build an invisible defense line for patients." This is what Xu Ji often says. This quarter, she led the team to deeply cultivate the main responsibility implementation of the drug marketing authorization holder (MAH), and with her keen insight into drug safety monitoring and accurate judgment of risk assessment, she successfully intercepted a number of potential drug safety incidents, making the word "safety" the most distinctive label of the company's drugs.

This professional adherence has not only won the high praise of the provincial Adverse Drug Reaction (ADR) monitoring center for "rapid response and standardized handling", but also won the commendation of the National ADR Center. When the recognition at the national level becomes a business card of the enterprise, "compliance" and "reliability" become the most powerful pass in the market competition. Behind this honor is the company's practice of the concept of "drug safety is more important than anything else", and it is also the industry credibility that Xu Ji and her team have won for the company with their professional capabilities.

2. Establishing a Career with Excellence: "Zero Error" Defines Industry Benchmark

In the core battlefield of drug vigilance in ADR report processing, Xu Ji interprets the word "responsibility" with a "nitpicking" attitude. This quarter, the 639 adverse drug reaction reports she led the handling of had no overdue reports, no missed reports, and no details that did not comply with the Timeliness rate 100%, completeness rate 100%, compliance rate 100% of the "three hundred" record.

In the face of emergency and serious cases, she established an emergency mechanism of "1-hour response, 24-hour follow-up, and full closed-loop management": she immediately linked the business manager of the area to lock the source of risk, personally followed up on the cases that needed follow-up, and recorded every data from the dosage to the patient's physical signs. As she said, "Every report is a life, and the more careful we are, the safer the patient will be."

3. Empowering with Innovation: "Technology + Artificial" Makes Risks Nowhere to Hide

"Traditional manual screening is like looking for sand in the desert. We must use technology to speed up efficiency and use manpower to ensure accuracy." Xu Ji knows that risk signal detection requires both speed and accuracy. To this end, she innovatively constructed a double insurance model of "computer-aided data mining + manual in-depth research and judgment". Relying on the company's "Insight Network Platform", she realized real-time monitoring of drug safety data. Once an early warning signal appears, the system automatically pops up a reminder, and she and her team complete the preliminary analysis within 15 minutes, and form a disposal suggestion within 30 minutes to report to the decision-making level, so that data becomes the "clairvoyance" of scientific decision-making; at the same time, she insists on carrying out manual signal detection every six months, and the annual analysis completed in July this year, By comparing the adverse reaction data of the past 5 years, 2 potential risk points were identified in advance, providing key basis for product iteration and upgrading. This model of "technology to improve efficiency and manual bottoming" has increased the efficiency of risk identification by 300% and reduced the missed detection rate to zero.

4. Gathering Strength with Collaboration: "All-Staff Consensus" Builds a Safe Community

"Drug vigilance is not a battle of one department, but the responsibility of the whole company." Xu Ji always believes that the strength of the safety defense line depends on the vigilance of every link. To this end, she took the initiative to shoulder the important task of cultivating the safety awareness of all employees, and assisted the leaders to create a training system of

From the "risk signal identification" of R&D personnel to the "adverse reaction collection skills" of sales personnel, from the "quality traceability points" of the production workshop to the "compliance awareness cultivation" of the administrative department, she transforms professional knowledge into easy-to-understand cases, so that the concept of "no small matter in drug safety" penetrates into every position. This kind of "unity of purpose" safety consensus makes cross-departmental collaboration smoother, and also upgrades the company's safety defense line from "single-point defense" to "full-domain prevention and control".

In seven years, she has grown from a drug vigilance "new recruit" to an industry-recognized "expert", and what remains unchanged is her dedication to "drug safety". When zero-error reports are stacked into a "safety barrier" for patients, when national-level commendations become the company's "compliance medal", and when the safety awareness of all employees is condensed into the "invisible armor" of development, what we see is not only a person's persistence, but also a company's commitment to "guarding life and health".

Xu Ji's story is an epitome of the "excellence and dedication" of countless Jiangsheng people. On the road of drug safety, it is precisely because of the silent guardianship of such a group of "unsung heroes" that the company can move forward steadily in the balance of innovation and compliance, so that drugs can carry the weight of "reassurance" and "trust".