Drug Safety-Pharmacovigilance Data Management Training.

Qtech-Sol Professional Development Center" is Private Career School (Since 2000), offering Title and Job focused Clinical Science Practicum and Certificate Programs. Its Center for Career & Professional Development specializes in offering Career Advancement programs towards Clinical Research and Trials, Drug Safety-Pharmacovigilance, SAS Data Analytics, and Reporting, Clinical Research Data Management, Clinical Research project Management and Healthcare Business Analysis. Our certificate programs are backed and approved by New Jersey Department of Education (DOE) and the Department of Labor and Workforce Development (DOL), USA. We encourage students to take advantage of this educational learning offered, meeting to the learning required per job market and as hired by Pharmaceuticals, Medical Devices, Clinical Research Organization (CRO) and Research Hospitals.

DRUG SAFETY-PHARMACOVIGILANCE

Introduction

Every day the Food and Drug Administration (FDA) works to balance expeditious access to drugs with concerns for safety, consonant with its mission to protect and advance the public health. The task is to review and look into diversity of patient indicators and how they respond to drugs, the conditions being treated. Reviewers in the Center for Drug Evaluation and Research (CDER) at the FDA weigh the information available about a drug’s risk and benefit, to make decisions in the context of scientific uncertainty, and integrate emerging information bearing on a drug’s risk-benefit profile throughout the lifecycle of a drug, from drug discovery to the end of its useful life. These processes may have life-or-death consequences for individual patients, and for drugs that are widely used, they may also affect entire segments of the population. FDA and the Department of Health and Human Services (DHHS) announced a series of steps to address drug safety, including asking the Institute of Medicine (IOM) to convene a committee to assess the US drug safety system and to make recommendations to improve risk assessment, surveillance, and the safe use of drugs.

Background and history

The concept of drug safety, also called “Medication Safety”, is not new, especially in the developed countries in the field of health. For instance, we find in the United States of America (USA) an experience for more than a century in the field of the safety of medications, and the use of these drugs led to creation of new acts or changes to the existing ones. For example, in October 1937, the use of the antibiotic sulfanilamide caused the death of more than 100 people in the USA. These deaths were not due to the active ingredient itself; rather, they were caused by the addition of diethylene glycol (DEG), the excipient used as a solvent for the active drug. DEG was supposed to be inert, with no therapeutic benefits; however, it was the toxic substance that led to those fatal side effects. The company claimed they did not foresee these side effects, which was true, as they did not commit animal studies before they marketed the drug. Because of this incident, the U.S. Food and Drug Administration (FDA) approved an act to ensure the safety of any drug by conducting non-clinical and clinical studies before the drugs are marketed for public use

Drug safety facts

All drugs have side effects, but the extent of their impact and severity varies from mild (such as mild itching or mild headache) to severe (such as severe rash, damage to vital organs, primarily the liver and kidneys, and possibly even death). Most of the side effects are predictable and mentioned in the leaflets for each drug. However, the serious problem is that some of the drugs’ side effects are not previously known or have not been noticed, and the real risk here is whether they would exert a severe deleterious impact on the patients who are using them. Among the factors that may increase the severity of the side effects, the type of medications and the type of patients using them are the most important

Specific patient populations and drug safety

The type of patients using medications is a very important factor in considering drugs’ side effects. People vary in their responses to medications according to their age. In addition, responses to drugs vary between males and females due to the physiological differences between genders. In addition, there are patient groups that need greater attention and care when using medications, such as pregnant women, the elderly, and children.

Drug safety and drug–drug and food–drug interaction

Different medications can interact with each other and cause what is known as drug interactions, which can occur with almost all drugs. Such interactions could occur at any stage while the drug is present within the body. These interactions could either reduce or increase the effect of other drugs, or could produce a different, new effect. Drug interactions can occur in any pharmacokinetic (PK) process, including absorption, distribution, metabolism, and excretion. All these PK processes are important, and it is therefore crucial that patients should consult a physician or pharmacist about the possible interactions that may occur between drugs and with certain foods to avoid undesirable effects.

Minimizing drug side effects

As previously stated, each drug has its side effects; however, it is possible to avoid these side effects by using the drug in the proper way, and by following the instructions included in the drug leaflet or provided by the pharmacist or the physician.

Conclusion

Drug safety is the main aspect of medical therapy that can play a major role in deciding which drug should be given to a patient. Also, considering the concept of benefit–risk balance, we found that drugs with a high-risk profile should be avoided unless needed. Drug safety has gone through different stages from the last century and till now and there have been several tragedies that we should learn from to protect our patients. All patients should be protected; nevertheless, specific groups of patients should be given more care, such as pregnant women, children, and the elderly, since they are considered vulnerable populations. Drugs can react with other drugs or foods used on a daily basis and specific precautions are required to avoid these simple but dangerous interactions. However, the risks from medications could be minimized through patient education about drug safety and openness with the patient, allowing him/her to ask questions related to their disease or medications. A good relationship between the medical team and the patient is one of the most important determinants for drug safety.

Career paths in PV / Drug Safety

Drug Safety has a very straight forward career path with the potential to work in both permanent and contracting capacities. Depending on the level of exposure achieved, career progression in Drug Safety can lean towards line management, or a more technical direction which includes signal detection, risk management and epidemiology.

As a Pharmacovigilance or Drug Safety Scientist your role will be focused on the detection, evaluation, knowing and prevention of adverse effects (AE) of drugs. You will also have a role in assessing the risk/benefit of products to ensure that they are safe to use.

Starting level titles tend to be Drug Safety Associate or Drug Safety Coordinator where the focus is mainly case processing; which involves doing data entry of cases; making sure drug identifiers are captured correctly, and the event reports are detailed enough for the evaluator to decide on the cause of the adverse event.

Once you have achieved 2-3 years experience you will be skilled in narrative report writing (providing a summary report of events to readers who do not have access to original data sets, so that the reader is able to come to a conclusion on the adverse event), medical coding using MEDdra (the most commonly used system to achieve a global standardization across regulatory agencies, to code adverse drug reactions) and have a good ICH-GCP understanding. You are likely to apply for roles such as Drug Safety Scientist or Clinical Drug Safety Officer.

With a good narrative writing background you can move into reviewing and, over time, writing and authoring PSURs (Periodic Safety Update Reports, DSURs (Development Safety Update Reports) and RMPs (Risk Management Plans). With the authoring experience you can then start exploring roles like Drug Safety Medical Writer or Aggregate Report Writer.

With 6-8 years work experience in these positions you can easily become a Team Lead or Team manager, ultimately achieving the title of Associate Director, Director or Vice-President.

What does a Drug Safety Associate (DSA) do?

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they’re on the market. Using standardized guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department.

Being a significant part of the pharmacovigilance and safety services (PVSS) department, a Drug Safety Associate (DSA) is a key job profile for drug safety management in clinical trials and post marketing surveillance (PMS).

Once a drug has been marketed the work for a DSA begins after. As soon as an alert of a serious adverse event (SAE) is raised the clock starts and sets into motion the necessary tasks that need to be completed to process the events.

In a life-threatening case, or in the case of death, DSAs are given 1-2 business days to process the necessary information and pass it onto other teams. Other medical cases including hospitalization, significant disability, congenital anomaly or other medically important events require this process to be completed in 2-7 days

Fortunately, DSAs receive a variety of support both from their own study team colleagues and the other departments. They have internal interactions with the Drug Safety Physicians (DSPs) from PVSS for medical assessment of safety cases. Furthermore, DSAs can expect external interactions with other departments such as the data management team (including Clinical Data Lead and Project Manager roles) for eCRF enquiries.

Similarly, they report to the clinical operations team (consisting of Clinical Trial Assistants, Clinical Research Associates, Clinical Trial Managers and Project Managers) who act as the main point of contact for the SAE follow-up. The medical affairs team (Medical Affairs Specialists, Medical Affairs Managers) help detect non-reported SAE, while the safety regulatory group (Drug Safety Associates, Project Managers) submit processed cases to the competent authorities and other required recipients.

In 2019, the global clinical trials market was valued at $46.8 billion and is predicted to continue at a compound annual growth rate (CAGR) of 5.1% over the next seven years. Although the outbreak Covid-19 has interrupted the progress of clinical trials and shifted much of workforce towards a remote model, the industry’s drive to deliver a vaccine against coronavirus will create the momentum needed to support the market’s growth. With the clinical trials market set for a promising future, a DSA job offers great career prospects and the opportunity to work in a highly rewarding role that improves the lives of patients.

Drug Safety-Pharmacovigilance Data Management program (DSPM)

With increase in demand for more Drug Safety Professional hired by Research Hospitals, Pharmaceuticals, and various consulting organizations. We developed our basic certificate DSAT program in 2005 and later expanded to include advanced and additional modules (ADSA and AADS) in year 2009. Our team consists of Physicians, Pharmacy, Public Health, Statistics, Healthcare Administration and Computer science professionals.

Qtech-Sol (QPDC) Drug Safety training programs is backed and approved by US-Department of Education (DOE) and Department of Labor and Workforce Development (DOL (State of New Jersey) since 2015. Our programs are designed as self-driven distance learning programs with support, packed with various real-time exercises as tasks, along with solutions. These tasks are in par to duties and tasks performed in real-time by a Drug Safety Associate on real-world.

The mix of all 3 modules (DSAT + ADSA + AADS) is the current DSPM package program, packed with practicum needed meeting job needs. Based on highest Education Background and Prior experience students can apply from Entry thru Senior roles, after certification.

Career Positions (Entry-Level): Related Experience (if any) : 0-12 Months.
Eligible Job Titles to Apply: Pharmacovigilance Assistant, Research Assistant, Drug Safety Assistant, Patient Safety Assistant, Data Entry, Inspection Readiness Associate.

Career Positions (Mid-Level) Related Experience (if any) : 12-36 Months.
Eligible Job Titles to Apply: Drug Safety Associate, Pharmacovigilance Specialist, Patent Safety Quality Assurance, Occupational Health & Safety Specialist, Operational Specialist.

Career Positions (Senior) Related Experience (if any) : 36 Months and Above.
Eligible Job Titles to Apply: Local Safety Manager (LSM), Drug Safety Manager, Quality Safety Manager, Global Drug Safety Specialist, Therapeutic Area Lead, Medical Reviewer

Post Training Assistance (PTA Program) - Job Readiness Program.

Do your Know, most recruiters look for keywords that match to their client requirements. When you apply to a job, your resume competes against 250 other applicants, on average. It’s important that your resume stands out from your competition’s and showcases what you bring to the table. Get Started with PTA program and have your resume prepared well to be successful. Students connect with us to gain the practicum needed, get referral and avail help on Resume preparation, Narrative Writing, and avail Interview mock session. These proven steps followed have helped many to achieve their career goal since 2005.

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About Qtech-Sol

Qtech-Sol Professional Development Center (QPDC) certificate programs are backed and approved by New Jersey Department of Education (DOE) and the Department of Labor and Workforce Development (DOL), USA. We primarily focus on Clinical Research and Trials, Drug Safety-Pharmacovigilance, SAS Data Analytics, and Reporting, Clinical Research Data Management, Clinical Research project Management and Healthcare Business Analysis.