The Benefits of Pursuing Pharmacovigilance Course

India’s pharmaceutical business is growing rate of 12–14% per annum. It is emerging as a major hub and pharmacovigilance is in the spotlight for healthcare industry. Pharmacovigilance (PV) plays an important role by monitoring the adverse effects of medical drugs throughout the drug development process, clinical trial and even when the drug is marketed. Pharmacovigilance is also abridged as PhV and in layman’s terms, it is drug safety. The World Health Organization (WHO) defines “PV as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. PV involves rigorous monitoring and that might lead to withdrawal of many drugs from market or may prevent their commercialization in market at times.

PV course promotes clinical training and understanding of the risks and benefits of medicines, adverse events reporting, consumers and regulators on use of drugs. It also involves proactive reporting on the quality, safety and efficacy of medicines. The course covers key aspects of career which includes adverse event reporting, report writing, early signal detection, narrative writing, seriousness criteria assessment, risk-benefit management, information on regulatory bodies involved country wise. 

Benefit of Opting Pharmacovigilance as a Career Option:

PV is a well-defined employment option for medical, life science and pharmacy graduates with numerous opportunities. It is due to the pharmacovigilance professionals’, that drugs in the market are safe for consumption and harmful drugs are often withdrawn from the market. Globally, many pharmacovigilance centers are working towards drug safety and are maintaining large databases. which pushes the pharmaceutical companies to outsource their work to countries like China, India etc. for cost effectiveness. This provides an opportunity to get jobs in various pharmaceutical companies and earn attractive package.

Responsibilities of Pharmacovigilance Professionals:

• Serves as the main link between pharmaceutical company and healthcare experts to provide valid information on drug safety
• Ensures that drugs are safe for patients and identifies any new safety information (signal)
• Handles adverse event in safety database
• Flags up early warning signs of adverse effects of drugs

Firms that appoint Pharmacovigilance Professionals:

Pharmacovigilance students can find enormous employment options in the following organizations:

• Contract research organization (CROs)
• Pharmaceutical companies
• Biotechnology firms
• Regulatory authorities and drug safety consultancies
• Regional pharmacovigilance centers and hospitals
• Knowledge process outsourcing (KPOs)

Average Pay-scale in PV:

• Fresher: Rs. 20k-45k
• After 5 years: Rs. 80k-1 lakh
• After 10 years: earn up to Rs. 3 Lakh

Opportunities in Pharmacovigilance

Figure 1: Career Ladder in Pharmacovigilance

PV offers jobs in report processing, in literature search and medical review, aggregate report preparation, screening and reporting, pharmaco-epidemiology, and risk management, labelling etc. 

Courses Offered:

The government is also supporting and emphasizing institutes to train students on PV as they can understand adverse effects of pharmaceuticals and work for human wellbeing. There is huge need for well qualified and trained people who could take PV jobs in drug companies. If a student or professional needs to strengthen his/her resume, there are specialized certificate and diploma courses to grab better opportunities.

Turacoz Skill Development provides up-to-date training to professionals and students who would like to opt for various opportunities in PV. The courses provided by Turacoz are:

Professional diploma in pharmacovigilance

Post graduate diploma in pharmacovigilance & medical writing

Post graduate diploma in scientific writing & clinical research

These courses have been planned by pharma experts from the industry themselves and thus it covers whole pharmacovigilance theoretical and practical knowledge for industry. The primary aim of the Post Graduate Diploma Program in pharmacovigilance is to familiarize the student with the updated theoretical and practical aspects in Pharmacovigilance. Students enrolled in online and offline certificate courses will be given exposure to practical exercises, training in detection of signal, data entry in database. Thus, in these courses students and professional will get maximum exposure to practical skills required in PV planning and execution.

Conclusions: 

PV is a great employment option for pharmacy, medical and life science graduates. A career in PV requires suitable qualification and proper training for processing and analyzing data. The PV course provides adequate knowledge and up-to-date training to students who would like to opt for various career opportunities in PV. The skill development program and training in PV is important and are provided by various institutes in India. The course module covers basic principles of pharmacovigilance, regulatory compliance, quality assurance, safety monitoring and all the key aspects in PV. These courses are designed for the aspiring students to make their career in PV as they get maximum theoretical and practical exposure via course.


Author: 

Aayushi Ambastha

Pharmacovigilance Writing: The Vogue in the World of Medical Writing

Pharmacovigilance is a crucial element of drug advancement and marketing. Monitoring the safety of patients and identifying the adverse effects of drugs and their potential and benefits is a task which is highly regulated on a global level and is continued throughout a drug’s lifecycle. The consequences and end results of these analyses are presented to health authorities in form of periodic aggregate reports and other pharmacovigilance (PV) documentation like RMPs (Risk Management Plans) are in demand by regulations all over the world.

A pharmacovigilance writer plays a very important role in producing these documents and even managing them. An expert PV writer offers PV expertise, comprehensive knowledge of guidelines, regulations and other requirements, formatting, documents, content specialization, communication & writing and skills related to project management. The presence of these skills makes it certain that the submission of patient safety, information on safety level of drugs, adverse effects of drugs and the analysis of risk by the companies to the regulatory authorities are clear and steady throughout the entire course of PV documents and that these documents are drafted on time and in an effective and efficient fashion.

What is PV writing?

Pharmacovigilance (PV) writing focuses on each aspect of drug development making its way from clinical trials through required report submissions before getting authorization from the market and all the way to the post-marketing state.

Skilled writers are in demand who can apply their functional expertise and knowledge of clinical drug advancement to handle the technical specifications of the documents, so the end document meets all the regulations and guidelines.

During the phase of clinical advancement of any drug, safety and efficacy report of the drug is required in clinical trials. The reports are made up post determining the safety data from a considerable proportion while it is being submitted for the marketing authorization.

PV writers are involved in writing Benefit-Risk regulatory reports, all that while till the product is available. PV writers aim to bridge the gap between medical health experts and the general public through their analysis of drug efficacy and safety and thus help to build trust in patients regarding the usage of drugs.

To sum up, pharmacovigilance writers furnish in clinical drug advancement by offering their scientific competence in formulating the clinical plan blueprint and structure of clinical drug advancement programs so that the drugs can be developed accordingly for human use.

Why Choose a Career in Pharmacovigilance Writing?

Pharmacovigilance is an integral part of clinical research and is growing exponentially. Many PV centers are breaking a sweat to work on drug safety control but the issue that lies down beneath the surface is that pharmacovigilance is facing an extensive shortage of human resources and there is a huge demand for skilled professionals. When it comes to new drugs, one must be extremely careful as they take a long time to reach the market following the entire regulatory course which determines their safety and efficacy level to assure that they can receive a market authorization.

Where can you find a job as a PV writer?

A PV writer is hired by the following organizations:

·         Pharma companies

·         Contract research organizations

·         BPOs/KPOs

·         Regulatory firms

·         Regulatory consultants

·         Site management organizations

·         Government Regulatory Bureaus

How can You Commence Your Career as a PV Writer?

With the six-month diploma course in medical writing, pharmacovigilance and market research, offered by Turacoz Skill Development Program (TSDP), you can rest assured to have a reliable and competent entry into the world of pharmacovigilance writing.

The course offered by TSDP will help you in learning:

·         Fundamentals of clinical research

·         Drug disclosure and advancement

·         Fundamentals of pharmacovigilance

·         Literature search

·         Medical jargons

·         MedDRA, etc.

The course is designed keeping in consideration the industry standards and requirements and is taught through a blended mode. The course focuses on making individuals industry-ready and works beyond technical aspects to even groom them personally and professionally.

TSDP also provides placement and career development support. One can expect to learn all the basics of pharmacovigilance, new trends in PV and develop professionally to start their career as a pharmacovigilance writer.

We bridge the gap between academics and the practical skills required for medical writing.

To register yourself for this course, click here. To know more about TSDP and the courses we offer, write to us at trainings@turacozskilldevelopment.org

You Can Achieve Your Dream of Becoming a Medical Writer! Read This to Find Out How

Not every medical writer owns a degree in medical science. You must be surprised to know that becoming a medical writer is not that complicated as you think. Many people who own a degree in science cannot be writers. It takes a few extra skills and potential to be one. Your degree cannot define your skills and interest that is required for writing.

Keeping certain factors aside, there is a whole universe waiting for you. This post will tell you how you can enter the world of medical writing and establish yourself as a medical writer.

The common questions related to medical writing for an individual are:

• How do I venture into medical writing?
• Where to knock for opportunities in medical writing?
• How do I select the topic on which I will be writing?

Starters: How to begin with medical writing?

All your questions will be answered by the end of this post, so stay tuned.

For now, we will be kicking off with the basics. Starting with:

What is medical writing, to be precise?

This question opens an authentic can of worms of imperceptible answers.

Before stepping on this stone, let’s understand the concept of medical communications. Medical communication is divided into 3 main categories; medical writing, scientific writing, and health writing.

We will begin with scientific writing first.

Scientific writing:

It comprises of writing academic publications, scientific journalism and other types of technical writing. Its orientation is medical, but it has more to it. It focuses on the basic elements of science, industrial research, social science, etc.

Medical writing might not always look like scientific communication.

Health writing:

It involves writing of articles, educational content and other content which is oriented towards patients and consumers.

Some doctors have been successful bloggers too, writing about health. Blogging is not a cake-walk but you can certainly make big in it if you have the right skills and go on generating a great source of income.

You can also learn the required skills as it is never too hard to learn.

Main course: Medical writing

Finally, we are arriving at it: Medical Writing!

Medical writing is closely in connection with scientific communications and relates to health writing, too. It is more technical in nature and caters usually to B2B (Business to business) requirements.

It includes generation of well-structured scientific documents, inclusive of clinical research documents, writing for healthcare websites/magazines, news and journals.

It is further divided into 3 broad categories, discussed below:

#1 Regulatory Writing:

The writers involved in regulatory writing generally work with biotech organizations, clinical research organizations, pharma companies, and device manufacturers and government agencies.

The documents worked upon are core technical in nature. Regulatory writers communicate essential information to government bureau, regulatory authorities and other reviewers.

Summarizing of complex scientific and statistical information and data for getting reviewed by New Drug Application (NDA), is an example of regulatory writing.

The tasks that regulatory writers perform is crucial for the organizations dealing with the excessively expensive procedure of device and drug recovery, advancement and advertising.

Skills required to be a regulatory writer:

Having a scientific background may not hurt your back, but it is not a hard and fast rule to be from a clinical or scientific backdrop.

There are many courses which help you in learning the basics of regulatory writing. In the era with a strong presence of internet all over, grab a course which would help you in getting started with regulatory writing. Conduct research on various courses available and choose the one that fits your need.

AMWA (American Medical Writing Association) has its own course to offer. You can choose to go with these courses. This job has a high level of financial stakes and complexity, thus, people who prove their worth would be on the sunnier side.

#2 Promotional Medical Writing:

It comprises of educational content writing for a distinguishing product or brand. It is basically content marketing for the healthcare industry. Now marketing here does not mean lying and this part of medical writing holds its certain importance which should not be overlooked.

The purpose of promotional medical writing is not to mislead but promote and inform patients, readers or consumers about a specific brand or product/service. Promotional medical writing comprises of creating sales training materials, advertising copies, product monographs, etc. to drive readers to action..

Skills required for promotional medical writing:

There was a time when unethical people crept into promotional medical writing, but not anymore. Today, promotional medical writing is under great surveillance and is regulated well.

An honest and skilled writer would never go out of fashion, that is for sure and would make it big in this style of writing.

For you to be a good promotional medical writer, having some awesome copywriting skills would help a lot..

#3 Educational Medical writing:

Medical education comprises of the writings that the physicians are acquainted to see. You look for CME (Continuing medical education) organizations, disease monographs, board-review preppers and other opportunities in educational writing.

The motive behind this is to inform and educate readers about a specific product/brand/service, without making any biased conclusions and drawing them towards a specific brand/product/service. It is fact-oriented.

Physicians interested in teaching can write for the companies they prefer/like, be a part of a podcast or even tutor students. One can also play the role of subject matter expert for those who are not a pro in this domain.

The CME industry has opportunities flowing for contributors wanting to pursue careers in this domain. Every sort of communication commences with writers.

Skills required for education medical writing/CME:

You need to be informed about the subject you are going to write. A dynamic style of writing is going to gain you some plus points as the content is required to be informative and engaging at the same time. The focus is to keep your readers ‘awake’.

How to become a medical writer?

Another entry into the most googled ‘How to...’ series.

To be an impressive medical writer, you need to have below mentioned key qualities in you:

• Reading
• Writing

These 2 are essential for becoming a good writer. If you have come down all the way to this section of the post, then you already are a good reader. ‘Writing’ is the part where most of the people struggle. The below mentioned points will help you in easing the troubles with writing part-

• Create a portfolio

Your portfolio reflects your capabilities as a writer. This is very crucial when you’re thinking of becoming a medical writer. Compile your best work and showcase it to the prospective clients to make them believe that you are the best fit for them.

In case if you have not written anything previously, need not worry. The thing to understand is that you need to have something relevant for showing to the clients to make them hire or else they will hesitate in choosing you.

If you have not written/published anything earlier, now is the time. Write articles, posts, blogs or medical education case that will add to your portfolio or will be self-published, without actually being published.

• Make your own website

Let your modus-operandi be your website. It doesn’t matter if you don’t have clients currently. Have your own platform to publish your writings. In the era of internet and social media, it is very important to have your presence on the web, to get noticed by the right people.

Having your own blog and website will not only catch the attention of relevant people/clients but will also add as a source of additional income.

Getting your website might not seem an easy task. You must get a host; domain name and you also need to learn to maintain your website. It surely takes some time to see the results, but it is worth all your patience and wait.

Today, making a website is not that difficult as there are various companies helping you with it. Companies like Bluehost, WordPress, etc. give you the comfort of designing your own website. You invest a small amount and the benefits in comparison to the amount paid are huge.

• Go for guest posting

In case you don’t want to start with your own website, you can go for guest posting. There are extant platforms where you can pitch in as a guest blogger/writer. Find relevant sites for your content and start posting. Medium is also a good platform to start writing your posts. This will help you in getting exposure in terms of writing for the public.

• Don't hesitate in making professional surges

Networking is the best thing you can do to learn, grow and grab an opportunity. Join professional medical writing associations and form connections with your fellow members. Create a professional CV and upload it on the web so that people can have a look at your potential, skills, and qualifications. This will serve as an opportunity provider for you.

• Opt for Medical writing courses

To groom as a medical writer and learn and enhance your skills, go for various medical writing courses. There are various online medical writing courses that are self-paced and help you with what you need. These courses will help you learn better and improve your writing skills.

We, Turacoz Skill Development Program (TSDP), offer six-month diploma course in medical writing, pharmacovigilance and market research for which you can enroll by clicking here.

We make you learn the basics of medical writing and help you learn relevant skills and expertise and make you industry-ready.

Developing skills for medical writing

You need to get your head straight into this field if you want to see yourself earning decent in this profession, a few years down the lane. However, a little preparation prior to getting in this field is not a bad idea. Some people like to go by a game plan and learn the required skills before venturing into anything.

You can be one such individual who is prepared for the new role. Most medical writers are required to meet the passing cognition with AMA style of writing, exceptional writing skills, and detail-orientation. Work on your strengths and develop the core skills for medical writing. For instance, to be able to write well, you need to write more and more. Learning and practicing is the key. You can go for self-paced online courses and our six-month diploma course is available both in online and offline mode, giving you the comfort of learning from anywhere.

Soak up all the information that is available for free on the internet. Follow relevant blogs and websites. Read work published by other authors.

Hope this post helped you with your queries. To know more about us and the courses we offer, write to us at trainings@turacozskilldevelopment.org

To People Who Want To Start Pharmacovigilance Writing But Are Afraid To Get Started

Medical writing is a wise career option for all those who have a knack for writing and are into science. The recent years have seen an escalating demand for medical writers and pharmacovigilance is one such segment of it, which is gaining extreme popularity.

Science had developed with a great pace and advancements have been made into the medicine sector. Various new drugs are being developed for the treatment of various diseases. With the rapid inventions of new drugs, the question of the safety and efficiency of the drugs remain persistent. Pharmacovigilance tends to answer this question.

Pharmacovigilance writing:

Pharmacovigilance writing deals with every aspect of drug development. It starts with the clinical trials continuing with submission of essential reports prior to the market authorization of the drug and goes forward till the post marketing of the drug.

Skilled writers, who can put in the efforts and expertise in clinical development and various technical aspects into the various related documents, to make the documents authentic and in accordance with the guidelines.

When going through the clinical development stage, a drug is required to have accurate reports on the safety and efficacy in the trials. The adverse effect of the drugs and the safety levels are measured from the reports from trials.

Benefit-risk regulatory reports are the key document/feature for a pharmacovigilance writer. They write the analysis of the safety and efficacy of the drug with an aim to bridge the gap between healthcare professionals and public in general enabling patients to develop a trust for the drug.

To be precise, pharmacovigilance writers contribute in the clinical drug advancement by giving inputs using their expertise in developing the clinical plan outlines and structuring clinical drug advancement programs for developing the drugs for the use of masses.

Why choose pharmacovigilance writing as a career?

More and more clinical researches are being conducted today. Pharmacovigilance counts for an integral part of clinical researches. Various pharmacovigilance organizations are working on drug safety control. The pharmacovigilance systems are facing a major human resource crisis and there is a lot of demand for the pharmacovigilance writers who can work on various clinical documents focusing on the safety and efficacy of drugs and help in the various documents related to the drug development process.

New drugs take time to reach the market as before they are out for sale in the market for the patients to use, they have to go through strict trials wherein their safety and adverse effects are measured and compared with that of their efficacy and efficiency levels and it is analyzed whether or not the drug is capable of treating the desired ailment and if it is worth taking the risk, I.e. the ratio of risk is to benefits is compared and then further decisions are made. The drugs must go through certain regulatory phases to achieve the ultimate goal of market authorization.

Seeing the current demands for the pharmacovigilance writers considering the significance of pharmacovigilance in the clinical and medical sector, it is a wise option to go for pharmacovigilance writing.

Pharmacovigilance writers can find work at:

• Pharma companies
• Contract research organizations
• Regulatory organizations
• Government regulatory agencies
• BPOs & KPOs
• Site management firms
• Regulatory consultants

How to ensure a successful career in pharmacovigilance?

If you are among those people who want to establish themselves into the field of medical writing but are concerned about how to start, this post helps you resolve your concern. Turacoz Skill Development Program offers 6-month diploma course in pharmacovigilance medical writing, where the individuals are made to understand everything about this sector, starting from the basics to the advance course.

This diploma course is targeted towards providing industry’s practical perspective in clinical research, drug advancement, documentation during drug development procedure, drug safety and various pharmacovigilance skills required in the industry. The motive behind this course is to make a successful pharmacovigilance professional.

The scope of this course is not just restricted to domain-specific training, but also involves personality development. Turacoz Skill Development Program offers various other courses such as regulatory writing course, freelance medical writing course, scientific writing, etc.

To know more about the courses, you can write us at trainings@turacozskilldevelopment.org

To register for the courses, click here.

Medical writing made easy for you! This article is the answer to all your queries regarding Medical Writing

A career in medical writing is indeed a very lucrative option. Medical writing is the best for ones who know how to put their literary skills to use and have the knowledge of therapeutic domain. Starting off as a medical writer might not be that easy but, then, it’s not even that difficult as you may think.
Everything demands some efforts. If you need to see favorable results, you need to work upon your goals first and then you’ll pass with flying colors. There are many of us who want to be a scientific writer or regulatory writer, but we hold back ourselves thinking of how to pursue this field.
Well, knowledge of science and medicine can certainly give you an edge, but you still need some extra skills to get medical writing career work for you. The medical writing courses with Turacoz Skill Development Program help you chase your dream of being a medical writer.
You might not be from a medical background, but you can still make it into this field. All you need is writing skills, research aptitude and knowledge of science. The medical writing courses offered at Turacoz Skill Development Program (TSDP) help you achieve your goal.
TSDP has a wide range of courses to offer, which includes:
6 months diploma course on medical writing and pharmacovigilance
TSDP offers this course in collaboration with Chitkara University, Chandigarh. The course is intended to provide industry insights on:

• Drug advancement
• Clinical research
• Documentation for drug development process
• Generation of various medical writing documents
• Drug safety and pharmacovigilance skills

The course is designed with blended technology mode, making it easier for the candidates to learn and have access to learning material anywhere and at any point of time.
The course also takes up personality development and resume writing, with an intention to groom an individually personally. The focus is to make students understand how to land a job and develop an understanding of the basic scientific principles related to regulatory writing, pharmacovigilance and publication.
Certificate course on scientific writing and conference presentation
To be able to write for a publication, one needs to be organized, clear, original, pragmatic, ingenious and precise. This course helps the students build an insight about scientific writing and different approaches to publication writing, distinct guidelines, peer-review procedure, publication ethics and essential tools for article submission.
Individuals looking forward to work in a publication in the medical field can join this course.
Regulatory medical writing course
Regulatory writing counts as the most crucial element of pharma domain. The rapid advancements in science and medical field has led to generation of various scientific and regulatory documents. These documents play an important role when the companies need to get approval for their drug/device from the regulatory authorities.
A regulatory writer is required to work on various regulatory documents like informed consent forms, investigator brochures, protocols, Common Technical Document (CTDs), etc.
TSDP provides basic and professional regulatory writing training. The tenure of the course is for 4 months and it is designed keeping in mind the recent industry and regulatory guidelines and focuses on building a skilled professional.
Want to know more about us and our courses? You can visit us here. For any course-related or other queries mail us at:
trainings@turacozskilldevelopment.org
We are constantly working towards bridging the competency gap and shaping the career of students by making them industry-ready.