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Category Archives: Pharmacovigilance

Pharmacovigilance: 4 Key Challenges

The field of Pharmacovigilance focuses on quality of a drug, adverse effects associated with it, and medication errors, impacting the health care system. According to the definition put forward by WHO, pharmacovigilance can be defined as “the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem”.

For the uninitiated, pharmacovigilance is the constant process which involves identification and monitoring of the safe use of pharmaceutical products. The process thus helps minimize the risk of possible harm coming to the patients. As a part of their duty, Pharma Companies are compelled to conduct a pharmacovigilance and comprehensive drug safety audit to see if the proposed product is compliant with FDA guidance, and worldwide laws and regulations.

This article discusses few challenges to Pharmacovigilance –

1. Inconsistent reporting of the adverse effects

The biggest challenge of pharmacovigilance is the inconsistent reporting of the adverse effects. It is important to understand that adverse effects associated to a drug or a medical device may occur not only during a visit to the Healthcare Center, but even after a few hours after the drug adminstration. Patients often fail to remember or notice adverse events experienced and this leads to inconsistent reporting. There are other cases where the patients feel anxious and report discomfort as adverse events. Such wrong reporting leads to incorrect conclusions which further result in the withdrawal or suspension of drugs.

2. Challenges of spontaneous reporting

Patients or drug companies may voluntarily come forward to report adverse events, but under-reporting impact the post-marketing databases. It may also be observed that medical staff neglect reporting and avoid reporting the symptoms which they feel are not serious. This can sometimes lead to delay in the focus towards potential serious adverse events (which might differ from patient to patient) that require immediate action. When the effects of a drug or medical device are not reported spontaneously, then there may be a problem while marketing and distribution.

Another major problem in pharmacovigilance is due to miscoding and misreporting of the adverse events. The field of pharmacovigilance is all about formulations, dosage, time and length of the exposure to adverse effects, and when these elements aren’t reported properly, it becomes difficult to manage and analyze the data. This may also result in false alarms for adverse effents that are non-existent.

3. Priority of efficacy over safety

Smaller or new age drug companies tend to focus more on efficacy over safety during clinical trials and this results in the compromise in drug quality. It is important for such companies to understand that drug development depends on the balance between efficacy and safety.

4. Limitations in Published case reports

The best way to alert about the adverse effects of drugs or medical devices is by publishing detailed reports in medical journals. This is an efficient way to convey suspected adverse effects and drug hazards. However, only a small number of such cases are published, and the reports published regarding them are poorly documented. There are a few cases where there are delays in reports indicating the publication and occurrence of adverse events.

Pharmacovigilance as a career path offers bright future. The field has a lot of demand and it is evolving by the day. Hyderabad, the city known for being professional hub, hosts several pharmacovigilance training centers in its heart land – Ameerpet. For people looking for the best pharmacovigilance training center in Hyderabad, Joshi Medicode is the right place to get trained.

Along with the best pharmacovigilance training, Joshi Medicode also offers medical coding and billing courses including ICD-10 and Clinical SAS courses.

10 Reasons why should one get a career in Pharmacovigilance

Pharmacovigilance or drug safety is an important factor for assessing the risk involved in various pharma products and confirming their safety for the patients. Pharmacovigilance includes obtaining, monitoring, investigating, assessing and analyzing information from service providers and affected individuals.

Reasons why you should get a career in Pharmacovigilance

  1. Drugs appear to be safe and well tolerated when said, but in reality, the safety is very much unclear. The expert ensures the safety of the drug that is being produced and sent to the market. Side effects of the repeated use of the drug or when used with other drugs are read and studied practically.
  2. Pharmacovigilance provides evidence that will inspire public confidence and trust. Medicine-related problems like treatment failure, counterfeit, poor quality, drug interactions, and incorrect use are governed by the expert.
  3. Pharmacovigilance takes care of the vulnerable groups and plans accordingly for a group of people like pregnant women, breastfeeding mothers, elderly and young children.
  4. Pharmacovigilance gets to know of the unknown adverse reactions and interactions of a drug. You act very crucially in case of any uncertain adverse situation. Detection of the frequency of the reactions is also noticed by an expert.
  5. The power and authority given to a Pharmacovigilance is very important when compared to the rest in a team. The study on a particular drug can never be stopped without the concern of the expert responsible.
  6. A Pharmacovigilance expert keeps the market and the process moving. There are multiple requirements of the drug for various diseases and treatments. These drugs are carefully investigated and created under the expert’s guidance.
  7. A Pharmacovigilance expert not only looks forward to the human safety but they also try to minimize the exploitation of animals while testing a drug. An expert looks for an eternal way of creating a drug which can be less harmful and easily tested.  
  8. A Pharmacovigilance expert is supposed to be smart enough to prevent any preventable disease or treatment without much adherence to the drug. He/she must be able to tackle the situation with the least usage of the harmful and powerful drug.
  9. A Pharmacovigilance expert knows about the harms and benefits of a drug and the interim that be created during a certain disease or situation. Being one of the crucial roles to play in the pharma world, a lot of knowledge of different drugs is required.
  10. An expert in Pharmacovigilance is expected to be a knowledgeable and highly experienced personnel who would understand and act according to the benefits and harms a drug might cause to the humans. A patient’s disease must be anticipated and realized by a Pharmacovigilance expert more than a doctor.

Above are the various reasons for which Pharmacovigilance is considered not only a crucial role instead of a powerful stand in the world of health, fitness, and survival. The job requires many talents and confidence. If you have the above capability and surety, Pharmacovigilance is definitely a domain to look forward to.

In case, you are interested in the domain and need proper training, do look forward to various Pharmacovigilance courses and Pharmacovigilance training institutes for better knowledge.

5 Advices to those who are pursuing Pharmacovigilance as a Career

Pharmacovigilance (PV) or drug safety is an important aspect while assessing the risk/benefit of the various pharma products and confirming their safety for patients. It is the science of obtaining, monitoring, investigating, assessing and analyzing information from healthcare service providers and affected individuals on the side effects of the drug.

Why is Pharmacovigilance great to be opted as a career?

One of the excellent employment options for pharmacy, medical and life science graduates is getting into Pharmacovigilance. It is because of the Pharmacovigilance professionals that the drugs in the market are safe and all those which are identified hazardous are removed off the shelf. The Pharmacovigilance professional comes into the picture when any medicinal side effect is reported in proper databases and collect additional information and send reports to appropriate regulatory bodies.

How does the industry function?

Career opportunities in this field are very less, especially if you are not a doctor. Organizations related to the field are huge and their respective team is mostly located at different sites. Working in isolated departments exists for employees with very little technical exposure with the senior detection staff and risk management staff.

The Pharmacovigilance is not a management opportunity rather the employee has to work hard. The job is a little tricky expects a person to be intellectual, challenging and unexpected. If these are the qualities missing, then you must reconsider your option for joining the profession.

5 tips for pursuing Pharmacovigilance as a career

1. Consider your interest in PV

PV has multiple areas to be considered. Some are specialized jobs like Statisticians, Epidemiologists, IT and Computer experts. Therefore, think over what you are interested in.

2. Consider your educational qualification

you cannot get into PV with a normal degree. Instead, you need to have relevant education in pharmacy, medical or life science. The higher your educational qualification is, the more your opportunities would open to get into PV. The highest degrees being MD, DO, RPh, PharmD, RN, LPN, Ph.D., MS, BS, IT, Epidemiology, etc.

3. Get an experience first

Being a complex field of detection risks, most employers expect experienced candidates. Hence, if you wish to crack through your dream company and job, then make sure you have a certain number of practical experiences. This might give you an upper hand during any interview process.

4. Consider your place of work

Working in PV can offer you great prospects if you consider working for small pharma companies, sites with global activities, generic businesses and regulatory and drug safety organization. Therefore, a candidate must always try to get through these fronts to gain more knowledge and stability.

5. Build your conscience and be assertive

Being in the PV department requires you to be very attentive to minute details while analyzing risks and other factors of various drugs which are used by people. The experts are in charge of complex health information which needs to be precise and productive.

While you are on the job, you meet a lot many individuals. Hence it is required that you are self-assured and trustworthy.

Being one of the complex fields to handle in the pharma world, a lot of consideration is expected. Being a tough and critical job, patience and understanding is expected.

There are many Pharmacovigilance training centres providing Pharmacovigilance training. Try getting more knowledge on the subject before making a decision.

Why Choose a Career in Pharmacovigilance?

“A career in pharmacovigilance is quite interesting with a nicely described career path.” According to a market research published recently by ‘Transparency Market Research’ titled “Pharmacovigilance Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2014 – 2020”, the worldwide market for pharmacovigilance was almost 2,426.6 USD in the year 2013 and will cross USD 6,104.1 million in 2020 with an estimated CAGR of 14.2%.
There is a rapid career growth in this field which gradually brings one to respected positions with excellent salary packages.

Before getting into details let’s understand what pharmacovigilance is, what you are expected to do as a pharmacovigilance professional, career aspects and much more.

What is pharmacovigilance?
Pharmacovigilance also abbreviated as PV is the medical science related to the detection, evaluation, and prevention of adverse effects of drugs, biologics or any medical device. It includes the knowledge of both short-term as well as long-term adverse effects of a therapeutic in a post-marketing or clinical trial setting.

Importance of pharmacovigilance
Pharmacovigilance or drug safety is evolving as a strategic discipline for the drug development and pharmaceutical marketing companies and includes the tools, systems, and methodologies used in collecting, monitoring and evaluating adverse event data from patients using drugs, biologics, and medical devices in full compliance to the regulatory framework or guidelines.

Pharmacovigilance systems are planned to

  • Explore new information about risks related to drugs
  • Reduce the risk and providing more safe medication to the patients (Risk Identification and mitigation)
  • Confirm with secondary and primary research methods the risks (signals) identified
  • Be advisory for new drug or medicine discovery and development

Why should you choose pharmacovigilance as your career?
Pharmacovigilance is an excellent employment option for pharmacy, life science, and medical graduates. It is a scientific discipline that involves reporting and assessing the side effects of a medicine. It is mainly due to the function of Pharmacovigilance professionals that the medicines in the marketplace that we consume are safe, and all those that are identified as hazardous are taken off the market. Pharmacovigilance professionals continually monitor the safety of the medicines in clinical trials as well as the medicines previously being marketed in the market. Just after a therapeutic side effect is reported, the Pharmacovigilance professionals enter the event in appropriate databases, follow-up with the event to collect additional information and send these reports to regulatory authorities and other appropriate regulatory bodies.

Who hires pharmacovigilance, professionals?
People trained in Pharmacovigilance can find excellent employment opportunities in the following organizations:

  • Pharmaceutical Companies.
  • Biotech companies.
  • Contract Research Organizations (CROs)
  • Regulatory Authorities such as DCG(I), FDA & CDSCO
  • Knowledge Process Outsourcing (KPOs) such as Accenture, Cognizant, Sciformix Corporation, iGATE, etc.

Now when you know that there are numerous benefits of having a career in pharmacovigilance, why not set your pharma career high with this booming opportunity by getting trained at Joshi Medicode.

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