THERE ARE various departments within a pharmaceutical company that work together to research, develop, market, and distribute medical drugs. One relatively unfamiliar yet indispensable department is the Pharmacovigilance (PV) department, which is in charge of ensuring drug safety. The Yonsei Annals interviewed Chang Ha-yan, a pharmacist working for the PV team at Handok Pharmaceuticals since 2020, to gain valuable insights into the specialized field of pharmacovigilance.

Annals:  What is Pharmacovigilance and the role of the PV team?

Chang: The World Health Organization and South Korea’s post-market safety management standards for pharmaceuticals define pharmacovigilance as the detection, assessment, understanding, and prevention of the adverse effects of drugs. Thus, PV involves monitoring the risk of drugs from an early stage in the development phase and throughout the entire life cycle of a medicinal product.

   Even those without extensive knowledge of pharmaceutical sciences will know that drugs can be potentially harmful if not taken with caution. Pharmaceutical companies conduct clinical trials to assess whether drugs are safe for patient use, and to determine the appropriate dose needed for the drug to exhibit its desired effect. The PV team plays a crucial role in collecting data on the incidence of adverse effects from the clinical trial, evaluating the overall safety of the drug, and considering what the risks are and how to minimize the risk.

   Based on such data, the PV team prepares the Risk Management Plan[1] to submit to the Ministry of Food and Drug Safety (MFDS) for drug approval. Even after the approval, the PV team submits a report with a detailed analysis of the drug’s safety issues to the MFDS every 6 months for the first 2 years, and then every 1 year for at least 6 years. Even after 6 years, aggregate safety reports must be submitted in 5-year intervals.

Annals: What does your typical day at work look like?

Chang: The PV team mainly prepares documents to submit to the MFDS by the deadline, so there is no set schedule for a work day. The main responsibility of the PV team revolves around collecting drug-related safety information provided by the marketing team, consumers, and other sources such as the medical database and news sites. The collected safety information is then reported to the MFDS or a partnered company if there is one. We also aid in providing safety guidelines during clinical trials. Sometimes, our team will hold meetings with other departments such as Medical Affairs[2] and the Clinical Research Team, to discuss the safety issues regarding our products.

Annals: What are some skills and qualities required to work for the PV department?

Chang: Firstly, time management skills are crucial. As I mentioned before, a PV team member must meet deadlines in submitting safety reports as failure to do so can result in an administrative disposition[3] of the drug. Thus, the PV team must construct a timeline of the allocated tasks and set priorities to complete them on time. Secondly, a PV team member must adapt to a constantly changing environment, as the MFDS regulations are frequently modified and have to be monitored. For instance, last year, the MFDS guideline on filling out the “Adverse Event Incidence Table” changed from requiring cumulative to yearly incidence. The third quality that a PV team member needs to possess is responsibility; you could say that this is a character required in any field, but being responsible is especially important as a PV team member since we are subject to tight schedules. PV team members may have to sacrifice weekends as at least one member from the PV team must be on standby outside of office hours to keep track of a drug’s reported adverse effects to ensure timely submission of safety reports to the MFDS.

Annals: How has your undergraduate experience shaped your career?

Chang: I participated in a variety of extracurricular activities during my undergraduate years in order to explore my interests. For example, I participated in the Clinical Pharmacology Internship Program at Seoul National University Hospital, which was a five-day educational session where I had the chance to gain a more in-depth understanding of clinical trials. I also took classes through the Regulatory Science Summer Program at the University of Southern California, where I could gain a more comprehensive understanding of drug regulations outside of Korea, namely in Europe and the United States. Although these experiences are not directly related to PV, I believe they have contributed to forming my career's foundations.

   Additionally, I applied for an internship for the Handok Pharmaceuticals PV team after my fourth year of pharmacy school, and at Daewoong Pharmaceuticals for a few months as a part of the clinical rotations required by pharmacy school during the fifth year of the program. I believe that an internship is a must if you want to apply to a pharmaceutical company, as such experiences will greatly increase your career opportunities.

Annals: What are the academic requirements to work for the PV department?

Chang: Knowledge of medicinal products, including the pharmacologic effect and the character of ingredients, helps significantly with PV work. According to the Pharmaceutical Affairs Act, there must be at least one Safety Manager in a pharmaceutical company, who must be a qualified doctor, pharmacist, or oriental medicine pharmacist. The Safety Manager is the head of the PV department and is often a pharmacist.

   A graduate school degree is definitely not a requirement to work in a PV team, as working in the field requires different skill sets than those emphasized by the theoretical frameworks of academic discipline. Although graduate school experience can be of merit if the research topic is directly related to PV work, I personally believe that gaining experience in the field is more pivotal. Therefore, if the reason you are going to graduate school is to broaden your employment prospects, I would advise you to pursue studies in an area that genuinely interests you.

Annals: What motivated you to pursue this specific career path at a pharmaceutical company?

Chang: Since my undergraduate years in pharmacy school, I felt that I was incapable of memorizing the various drugs and compounds. Therefore, I thought I was unsuited to work at a retail pharmacy or a hospital because I would need to recall specific drug or health-related information when directly dealing with patients. Also, working at a company means there are no set boundaries to your work, as it is possible for a pharmacist to work in Human Resources, the marketing team, or even the IT department. Furthermore, I think that in comparison to pharmaceutical companies, the scope of work done at a retail pharmacy or hospital is comparatively restricted.

   Several factors led me to choose the PV team out of all possible positions in a pharmaceutical company. The main reason was that I had internship experience in this field. I felt that I was not particularly strong in coming up with creative ideas, and the stressful pressure of work performance steered me away from marketing, eliminating it from my career options. I also thought that clinical research was a red ocean that could be managed by experts from various fields other than pharmacy such as nursing and clinical pathology. Therefore, I narrowed down my choices to PV and Regulatory Affairs (RA)[4].

Annals: How has your experience been working at Handok?

Chang: Bigger pharmaceutical companies tend to have specialized and more categorized tasks which can restrict the scope of work one is able to do. I enjoyed my three years at Handok because I got to carry out a relatively wide range of tasks. I could work with Handok’s diverse product pipeline which has both Over-The-Counter (OTC)[5] and Ethical-The-Counter (ETC) drugs[6], including anticancer drugs and drugs for hypertension, diabetes, and rare diseases.

   The proudest moment while working as a part of the PV team would be when a drug gets finally approved, as it can then be used to help patients. I feel especially invested in this moment since—although the RA team submits the drug approval—the PV team provides the documents necessary for the process.

Annals: What is your general satisfaction level with your current job?

Chang: So far, I am satisfied with working at Handok in the PV department. In terms of work-life balance, there is greater flexibility in working hours and taking leaves from work compared to jobs in pharmacies and hospitals. Handok also implemented “flex-time,” allowing employees to freely adjust their daily working hours. As PV is a rapidly growing field, I am also satisfied in terms of future career development. I do not regret joining the PV team because there are always new challenges that prevent my work from getting repetitive or tedious.

Annals: What is your ultimate career goal?

Chang: My ultimate goal is to become a specialist in the PV field. PV is a relatively new field that is constantly developing, and with the growing significance of quality management, I want to be capable of managing the quality of drug safety information. Such management would entail meeting the standards required by the MFDS in terms of transparency and thoroughness of a pharmaceutical company’s drug safety surveillance process. Moreover, necessary measures would need to be taken to solve any issues through a systematic process known as Corrective and Preventive Actions (CAPA)[7]. I also wish to gain deeper insight into PV and hone my skills to be able to monitor and evaluate solutions that enhance the quality of future PV systems.

Annals: What do you think about the future of PV?

Chang: The Korea Institute of Drug Safety & Risk Management (KIDS), an MFDS-affiliated institution that the PV team works closely with, was established in 2012. It has only been about ten years since the issue of drug safety gained increased awareness and tightened regulations were imposed on drug safety. With this trend, the MFDS is raising the standards of pharmacovigilance practice. Whereas in the past the MFDS simply required incidence data of adverse drug effects, it now requires a more detailed analysis and evaluation of each effect, the causality between the drug and its effect, and responses that can be taken to alleviate such effects. I also believe that the current MFDS regulations will have to catch up with those of the United States Food and Drugs Administration (FDA) and the European Medicines Agency (EMA). As the MFDS will require more PV activities in the future, I believe the PV field will continue to expand.

Annals: Do you have any advice for students who aspire to work at a pharmaceutical company?

Chang: As I said before, I strongly recommend looking for internship opportunities. Additionally, showing a strong interest in the PV department is important as it is difficult to possess practical skills without any work experience. On the International Council for Harmonization for Pharmaceuticals for Human Use (ICH)[8] website, there are some global guidelines on PV activities, and studying such documents will assist you greatly in gaining a general understanding of the field of pharmacovigilance.

[1] Risk Management Plan: A document containing specific risks involved in a project and actions to mitigate those risks

[2] Medical Affairs: A department within a pharmaceutical company or medical device company responsible for communicating information to healthcare providers and managing relationships with stakeholders

[3] Administrative disposition: Actions taken by the government that can include the revocation of permission, report, registration, and approval of drugs, as well as suspension of a firm against drug manufacturing

[4] Regulatory Affairs (RA): The department responsible for obtaining approval for new pharmaceutical products and maintaining the approval after the product release

[5] Over-The-Counter (OTC) drugs: Non-prescription drugs

[6] Ethical-The-Counter (ETC) drugs: Prescription drugs

[7] Corrective and Preventive Actions (CAPA): A method of collecting and analyzing information about a product or quality problem and taking measures to prevent its recurrence

[8] International Council for Harmonization for Pharmaceuticals for Human Use (ICH): An initiative for discussion of pharmaceutical product development and registration