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Clinical Research concentrate on the drug and medical development equipment before it can be considered ready to be launched into general medicine practices. The drug approval for the common market place is a long and complex process which includes clinical trials. A drug or piece of equipment cannot progress to the next level without passing these trials. A clinical research will overlook the development of drugs and equipment through the stages of these clinical trials. There are different levels of careers in this field starting with clinical trials assistant all the way to clinical director.
In this world of rigorous competition, we’re supposed to either blend in or know exactly what to do. It is quite overwhelming that the social media feed only talks about success stories, job promotions and significant achievements.
Meanwhile, you’re stuck wondering what to do next. While you may be thinking that being confused is a bad thing, It actually helps you explore and consider unknown sectors you would never know otherwise.. When you have a problem, all you want is to fix the problem and move on, right? Same goes for your career and here I am to help you with my two cents. .
The life science industry is growing at an unprecedented pace. With constant research and technology available, various new devices and methodologies are being introduced in Healthcare Industry. With constant research it has become important to make sure that there are regulations for improvement of medical sciences. Its true concern on the part of the government role in a diagnostic process. This, it is essential on the part of government to maintain highest standards to regulate them. But It is not always easy to control the highest standards. On various occasions the concerned companies fail to retain the standard specified the concerned government authority. One of the main causes for such failure is lack of knowledge. But this can be successfully battled with perfect consulting and training processes.
Medical device consulting companies offer with specifically trained staffs who help in obtaining compliance and quality for all sort of medical devices. The proper methodology, tools and skills have a positive impact on the overall performance. For maintaining quality systems, medical device regulatory consulting is absolutely important. This will guide in meeting the hardest challenges posed by the regulatory authorities. One can pick from a various of medical device training courses. Its perfect to have complete coverage on all the problems arising inside the life science industry.
Its important for the companies to have professionals with effective risk management training. They need to go for training program that explains to identify budding issues, method for checking the issues and prevention of future re – occurrence of same situation.
Everybody is confused at some point and it can be in many forms. It can be to choose between two jobs or choosing a career or switching a career. Confusion can only happen if you care. You can create anything you want.
Now, let me help you:
➢ Consult an expert. Look around you. Do you see anyone who has the life or the career you want? . You can research about them online and check their profile history. You will notice not everybody has a straight career path. One has to do many odd jobs or one can just be lucky. You can talk to the interested people to know their journeys, learnings and unlearnings.
➢ Get a coach. It could be the same person as the one who inspires you. Whoever it is, they need to have a great understanding of the terrain you are in and have a sincere desire to serve your best interest without judgment.
➢ Clinical Research Associate – Working as a clinical research associate (CRA) is a very rewarding career. Responsibilities of a CRA include helping to set up a clinical trial and then monitoring trial protocol once a study is up and running. CRAs are required to have either a science degree or a nursing degree. A life science degree, such as in biology, pharmacy, or biochemistry, is the most useful degree to have.
➢ Pharmacovigilance – Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem. This is an excellent employment option for pharmacy graduates.
➢ Regulatory Affairs – Regulatory Affairs has grown rapidly due to the requirements of governing bodies to make sure the safety and health of the general public. The regulatory affairs industry focuses on tracking and regulating scientific development in sections like veterinary, pharmaceuticals and agriculture. There are a wide range of position in this specific field that controls all levels of regulation of various fields. Staffs in this field must have knowledge of various field when planning whether to certify the efficacy of a product while making sure they also comply with all legal framework needed.
➢ Medical Coding – Medical coding is not a simple data-entry profession. It requires certification to gain knowledge of medical terminologies, pharmacology, and anatomy for one to be able to comprehend patient records and charts. Medical coders from the clinical data management team process the medical terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed.
➢ SAS Programming – Responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study’s protocol or statistical plans. Base SAS certification is usually considered helpful in securing an entry-level job in analytics but make sure you have good programming skills.
➢ Biostatistics – Statistical analysis is an important part of clinical trials because it allows researchers to determine whether their results were meaningful on a statistical level. Clinical biostatisticians usually hold advanced degrees in biostatistics.
Clinical data management (CDM) is a critical phase in clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management assures collection, integration, and availability of data at appropriate quality and cost. Clinical data management plays an essential role in the data collection phase of clinical research.
The process of collecting and managing research data is done in accordance with regulatory standards to obtain quality information that is complete and error-free; the goal is to gather as much of such data for analysis as possible. The field of clinical data management (CDM) has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring qualityassurance standards be met in collecting the data used in the drug evaluation process.
Clinical data managers have a variety of educational backgrounds and professional experience:
➢ Minimum of bachelor’s or master’s degree in life sciences (e.g., biology, cognitive science, ecology, microbiology, immunology, molecular genetics, neuroscience, physiology, psychobiology, psychology) or clinical research management
➢ Post-master’s certificate in clinical data management or clinical trials in medical device and drug development
➢ Master of Science in clinical research organization and management
➢ Certification in Clinical data management, health informatics, or biometrics
➢ Post-bachelor diploma courses in Clinical Research and Clinical data management
Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.
Pharmacovigilance is a practice of maximizing the safety and benefit of drugs and lessening the risks and adverse effects. The techniques are employed when trails and afterward once a product is on the market to track any adverse events and side effects in order to protect the public. Efficient Pharmacovigilance is a legal requirement of any pharmaceutical organization and the penalties for failing to implement effective Pharmacovigilance practice are severe.
When a pharmaceutical organization is granted a license to release a drug to the market, it is granted on the back of various phases of clinical trials where the drug will have been tested firstly on healthy volunteers and then on patients going through from the condition that the drug is designed to treat. In various cases, the drug will be tested for a broad period of time on 1000s of people the intention being that as many of the adverse effects of the drug will have been seen during the clinical trials.
The licensing authorities will be a balanced act – on the one hand medicines should be safe as possible and they need to ensure that diseases are treated. In order to help attain this balance there are methods in place to make sure safety once a drug is on the market.
This might be needed if there are unforeseen long – term consequences of using the medicine or it is interacting in unexpected and unusual ways with other medicines or if the medicine turns out to be not suitable for use in specific populations that was suspected previously – for instance in the elderly or infirm. Also, very uncommon and potentially serious side effects might only be seen after the drug has been taken by a much larger number of people than might have been on the trials.
In order to almost guarantee finding a side effect that happens in one in ten patients, you have to offer the drug to thirty patients just to make sure of finding that effect. Pharmacovigilance is a science of drug safety, a blend of Pharmacoepidemiology and Pharmacology it offers the tools to help assess risk Vs benefit, to detect signals in data that point to an adverse event and to help assess the signal significance.
Pharmacovigilance solutions providers must be able to provide you complete services during the pre-marketing and post – marketing phases for every product. This simple rule can avoid having to waste time and also substantial amount of the budget handling over the new pharmacovigilance companies at various stages of a product life cycle.
It goes without saying that clinical trials can be performed successfully if the pharmacovigilance solutions provider can ensure the clinical trial safety data has been managed well. The query arises over whether the provider might be able to provide service throughout the trial programme, not just one trial or trial stage.
The law governing pharmacovigilance lay down rigid details on what pharmaceutical firms must do in the event of analysing a serious adverse event and indeed what constitutes a serious adverse event. With these major demands on pharmaceutical firms, its essential for them to set up a right pharmacovigilance system and this might cause a various of issues.
First of all, the regulations are usually tough to interpret specifically when it comes down to the finer points.
Second of all, if you get it wrong, you can subject to pharmacovigilance inspection and you might in time have the marketing authorization revoked for a specific product. So, there is a terrible lot riding on having effective solutions to hand on pharmacovigilance. As a pharmaceutical firm, you must have two choice: either do the whole lot in – house or outsource some of the pharmacovigilance operation.
One of the Pharma industry’s most essential sector focuses on drug safety called as Pharmacovigilance. This area of the industry related to finding and preventing side effects of the medicine or drug. This role entails researching, tracking, assessing and evaluation of details to pin point the possibility of adverse effects before launching onto the market. A career in this field might require to collect information from all parties included in the clinical trials as to be able to offer a safe assessment and report the findings to regulatory bodies and licensing agencies.
Drug safety offices are highly responsible for observing and tracking reactions and effects during the drug studies and trials. A report will be submitted to the authorities and the drug safety managers will plan, review and monitor the profile of specific medication products.
Drug Safety Physicians will assess and attain details about safety of the products. They are need to carry out medical case reviews and analyse product safety during clinical trailing.
Inevitably, In-house wages will be less than experienced staff. In-house employees already know the firm’s culture and systems and will adapt immediately to running and working in a pharmacovigilance department. Where you have marketing authorization for various products in various territories it makes sense to have experienced and dedicated employees to deal with drug safety where a smaller firm might be better off outsourcing the operation of pharmacovigilance.
You need specialist expert in pharmacovigilance department. You can get training, but where and at what cost? You might need a pharmacovigilance database that is validated, not just a spreadsheet in excel.
Then there is regulated training – pharmacovigilance training. If your hire the fresher’s trained by academics who don’t really know the industry? Or maybe they must be trained by formed regulators who have never had to work in a form so their knowledge is only theoretical? Or maybe you can have them trained by someone who used to work for the firm who might have no real idea about the regulators are thinking.
Or just you might someone who has experience of all 3 areas who can train your employees, someone accepted as a registered presenter for CPD certification service which means Continuous Professional Development. Such people are out there but not easy to find. When you look at the qualifications of the people performing the training at the conferenced and in – house, these are the kinds of elements that must influence the decision to attend – do the presenters have the right experience so that the employees and you know what you want to in these sessions?
Discussion of the requirements of the legislation in the European Union is continued on the information service website of pharmacovigilance with specific emphasis on volume 9 of the governing rules medicinal products on the European Union, which has the guidelines for medical products for both veterinary and human use.
There are various training institutes offering theoretical training’s in Pharmacovigilance but very few that have been providing practical training on safety databases with all the regulations.
Keeping the challenges faced by fresher’s, Gratisol Labs is providing extensive theoretical & practical training of safety databases in Pharmacovigilance. All the topics will be presented by team of Drug Safety Physicians & Drug Safety Associates. It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event) , Data Entry, Case Processing, Medical coding & Narrative Writing.
➢ Knowledge of clinical trials/ drug development process.
➢ You will be working in a highly regulated environment and should have an expert understanding of GCP, ICH, and other relevant regulatory requirements to ensure that studies are conducted compliantly.
➢ Clinical data personnel are required to be detail-oriented as the success of the clinical trial depends directly on the team’s precise collection of data.
➢ Good decision-makers to decide on data collection methods and data collection suppliers.
➢ Once you are on-job, Clinical data managers also need to be critical problem solvers, because unforeseen issues are bound to occur during the execution of a clinical trial.
➢ Data entry associate – Tracks the receipt of CRF pages and enters data into a database.
➢ Clinical Data Associate – Clinical Data Associates are accountable for proper capturing, recording, documenting of clinical research data for clinical study and validation. Clinical Data Associates must make sure that studies or protocols are completed consistently.
➢ Clinical Data Coordinator or Clinical Data Specialist – Conduct data management tasks for data review, writing and clearing data clarifications. Designs the CRF, prepares the filling instructions, develop protocols and other important documents involved in CDM. Inform Data Manager on project status and potential problems regularly. Review CRFs and electronic clinical edit programs and generate and resolve data queries. Review clinical sites and edit listing and checks and generate queries and update databases. Identify and comply with working instructions and core operating procedures. Handle external vendor Clinical Data Management System to ensure vendor quality service on budget and time.
➢ Database programmer or designer – DB Programmer performs CRF annotation, creates the study database, enables data validation, designs data entry screens and performs edit checks using dummy data.
➢ Lead Data Manager – The senior clinical data manager is typically responsible for managing all aspects of clinical data management activities. This often includes tracking the completeness and validity of the clinical database, devising the data management plan, and participating in the creation and subsequent management of standard operating procedures. A senior clinical data manager is often required to have several years of clinical data management experience, and an undergraduate degree in a related field.
➢ Clinical Data Manager – Clinical Data Managers monitor work productivity or quality to ensure compliance with standard operating procedures. They process clinical data, including receipt, entry, verification, or filing of information. Supervise the work of data management project staff and handle a team of 10-15 or more. Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems. Analyze clinical data using appropriate statistical tools. Design forms for receiving, processing, or tracking data.
➢ Write a crisp and professional resume to get interview calls. Your resume is your first interaction with an employer that can help you highlight your skills and strengths, and thereby, catch recruiters’ attention.
➢ Guide the recruiter to the conclusion that you are the best candidate for the clinical data management job. It is actually very simple. Tailor your resume by picking relevant responsibilities and add your accomplishments. This way, you can position yourself in the best way to get hired.
➢ Craft your perfect resume by picking job responsibilities written by professional recruiters.
➢ Pick from the thousands of curated job responsibilities used by the leading companies. Tailor your resume by selecting wording that best fits for each job you apply.
➢ Readability – Succinct and to the point i.e. your CV should be easy to read and keep your CV short and simple.
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Hope you enjoyed reading this article and thanks for sparing your little time. It’s time to step up and lead yourself into the future. In the end, no matter what path you take, you are still creating your career. Have fun with it!
“It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”
All the best!
Subject Matter Expert - Pharmacovigilance
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