Tag: Life Science sector

Role of Pharmacist in Pharmacovigilance Field

The Pharmacy profession has experienced significant change over the last two to three decades. Pharmacists can use Pharmacovigilance systems interfaced with electronic health records to observe the drugs they fill and recognize adverse drug reactions quicker than non-pharmacists, thereby decreasing expensive healthcare costs.

Pharmacovigilance information systems managed by pharmacists can recognize adverse drug reactions in emerging countries where quality control of medicines is questionable. Reports suggested that patients had insufficient knowledge about their prescribed drugs, although they had been using them for a while.

73% of pharmacists work in hospital or pharmacy settings, where they can face events based on adverse drug reactions or other drug-related problems. Their involvement in pharmacovigilance systems is crucial.

The development of electronic information systems has been a milestone in identifying and intervening drug-related problems such as dosage, adverse reactions, interactions, compliance, or ineffectiveness. Such decision support systems in electronic medical records can capture drug-drug interactions or identify other issues (e.g., contraindications) with prescriptions before they are filled

Pharmacists have a crucial role in the US and health systems to maintain the rational and safe use of medication, for they are drug experts who are specifically trained in this field. They ensure that the drugs in the marketplace we consume are generally safe, and all those identified as hazardous are taken off the market.

Pharmacovigilance is an excellent employment option for medical, pharmacy, and life science graduates. It has resulted in pharmacists taking on greater responsibility in managing minor illnesses and delivering public health interventions. There is no limit to the patients dealt with by pharmacists.

In the pharmaceutical sector, the number of career opportunities is nearly limitless. Pharmacists can play a role helping patients with chronic diseases have better medication at the correct time and get good clinical outcomes. Pharmacists serve as patient advocates, contributing information that permits patients to evaluate risk and improve their autonomy

The pharmaceutical industry in the US is one of the most advanced industries of the country and the third-largest in the world. It is technologically strong and self-reliant. Effective use of pharmacists’ workforce will improve the outcome of pharmacotherapy and decrease global health costs.

Pharmacists can fully use their clinical abilities and usually involve diagnosis and therapeutic management. More than ever before, community pharmacists are now in a position to identify, record, and report medication safety incidents.

Sollers’ Drug Safety and Pharmacovigilance certification help Pharmacists to enrich their career growth in the Pharmaceutical sector. It might seem like a lateral move at first, but it will open more fantastic opportunities in the long term.

May 27, 2021
Evaluation of Adverse Drug Reactions
Pharmacovigilance is an arm for patient safety and care that aims to get the best results with medicines’ treatment. Unfortunately, because of many different factors, any medicine can sometimes cause adverse reactions.

As we can see, the world of 2021 is different compared to previous years. We are now cautiously reopening and trying to get into the new normal state. Pharmacovigilance will recognize the risks in the least possible time when the medicine has been marketed and will aid to build and/or classify risk factors. When communicated adequately, this data enables intelligent, evidence-based guiding with potential for stopping many adverse reactions and will finally benefit each patient to obtain optimum therapy at a more economical cost to the health system.

Adverse outcomes, preventable or otherwise affects the treatment. Mainly adverse events affect patients, but they also affect health care practitioners. Revealing information about adverse events has benefits for the patient and the physician and, ideally, strengthens the patient–physician relationship and promotes trust.

When to report

A patient should communicate if they had a notable outcome.They can go to hospital and inform the medical advisers that they stopped using medication as they have this type of adverse reaction

FDA encourages the consumers to report whenever they find any adverse reactions. If the team gets bundles of reports about the same medicine they will respond and take possible actions.

What happens after a report is made?

FDA examines all submitted reports and identifies the similar adverse events occurring with a specific medicine.

Depending on the severity of the adverse reactions, FDA may take any of the following decisions.
- Withdraw the medicine from the market
- Declare a drug safety communication to notify public
- Set some restrictions on the drug distribution
- Renovate the drug’s labelling, insert or package.
But almost everything starts with consumer feedback. Adverse event reporting allows us to do our job and report needed information back to consumers.

Types of Adverse Drug Reactions:

Mainly it is classified under
- Dose-related
- Allergic
- Idiosyncratic
In detailed it is segregated as

Type A – Augmented

Reactions which can be predicted from the known pharmacology of the drug. These are dose dependent.

Ex: Bleeding, Headache etc.,

Type B – Bizarre

These are adverse reactions that depend upon promoting the growth of certain microorganisms and cannot be predicted from pharmacology.

Ex: Anaphylaxis, Hypersensitivity

Type C – Chemical

Several adverse reactions rely upon the chemical nature of a drug rather than pharmacological properties and cause chemical irritation.

Ex: Hepatotoxicity

Type D – Delayed

These reactions occur because of the physical nature of the formulation or the method of administration.

E.g. Chemotherapy, Secondary tumours, Teratogenic effects

Type E – Exit/End of treatment

These are known as withdrawal reactions, these occur on withdrawal especially when drugs are stopped abruptly.

E.g. Phenytoin withdrawal Seizures, Steroid withdrawal

Type F – Familial

Familial dysautonomia is a hereditary sensory disorder. It is a genetic disorder that affects the development and survival of certain nerve cells.

Ex: poor muscle tone (hypotonia), frequent lung infections, and difficulty maintaining body temperature.

Type G – Genotoxicity

Several drugs can create genetic damage in humans. Distinctly, some are possibly genotoxic or carcinogenic. Few, but not all, teratogenic agents harm genetic material within the fetus.

Type H -Hypersensitivity

These are side-effects induced by hypersensitivity or allergy. They are apparently the most frequent adverse reactions after Type A reactions.

Type U – Unclassified

Some adverse reactions have a mechanism that is not known. This may constrain the introduction of new adverse reaction divisions in the future. Examples include muscular adverse effects,drug-induced taste disturbance.

Drug Safety and Pharmacovigilance Training Program accomplish the demands of this ever-growing and profoundly regulated industry by offering a curriculum aligned with the real-time industry requirements, highly competent, and equips career readiness for professionals in the pharmaceutical industry.
March 17, 2021
Rising Significance of Risk Based Monitoring in Coming years
The complexity and cost of clinical trials have increased dramatically in recent years.With rapid advancements in Clinical trials, the methodologies used to support vital clinical trials are necessary to protect patient safety. Efficient monitoring is becoming critical to protect the well-being of trial participants and to maintain the integrity of final results; Risk-Based Monitoring is now generally accepted that the process for clinical trial monitoring needs to change. As the inclination towards using Risk-Based Monitoring increases there still remains an inertia to opt for this method.

The importance of Risk-Based Monitoring:

Taking a risk-based approach to study quality and the monitoring of any clinical investigation has a simplistic focus:
- Recognize potential threats
- Create a plan to monitor those activities
- Improve monitoring methodology as needed
Centralized Monitoring:

A combined approach based on the recognized risk at each study site.

Remote Monitoring:

Utilization of low-cost clinical resources to perform monitoring activities that do not need onsite visits.

Reduced Monitoring:

SDV approach concentrates on patient visits, critical data, and selected patients, depending on the trial’s risk-benefit profile.

Triggered Monitoring:

Depends on predefined trigger points such as patient enrollment rate and reported Serious Adverse Events (SAE).

Let’s discuss the few essential needs for this:

Data Agnostic Integration:

In the ever-changing Clinical trial landscape, patient trends, and data requirements, RBM needs a technology platform to future proof against the challenges. Acquiring an agnostic integration platform can help a services business remain agile.

Risk-based monitoring(RBM)marks a paradigm shift from analyzing each piece of data from a trial to a more engrossed analysis that happens in real-time. Agnostic integration is a platform that can interface with any operating system and database, preventing incompatibility, data corruption, and vendor lock-in. An agnostic approach is to simplify integration between critical systems of record and other apps that help the service’s business lifecycle.

User Friendly Interface:

A clear dashboard provides an edible format for the users to spot difficulties early and is significant. Clear and easy-to-use data visualization requires to be combined with quick access to the data below to let study teams examine data in detail down to the levels of performance by site or country and create bespoke reports. Make convinced the platform you choose uses clear and steady navigation routes that are recognizable to users.

INTELLIGENT MONITORING

Part of the power of RBM is enabling sponsors and CROs to move to more intelligent monitoring methods that can direct resources to monitor the sites or subjects who are at the most significant risk. Ensure the technology platform you select supports intelligent monitoring with real-time visualization and flags of trial-level issues like recruitment delays or protocol deviations. Early oversight of risk empowers you to quickly identify problems and roll out prompt interventions, like protocol amendments.

When sponsors and CROs leverage available technologies and develop a risk-based monitoring plan upfront, it leads to less data collection for site personnel and less on-site data monitoring by CRAs. Clinical trials without efficient data collection technologies will continue to rely on the sites to scan pages and pages of documents so that CRAs can monitor remotely. This is not the intent of risk-based monitoring. For risk-based monitoring to work for sites, the trial must be designed to collect and analyze the data more reflectively and efficiently.

Risk-based monitoring is taking over as it promises greater accuracy, lower prices, in-depth analysis, and timely results. The Short-term Program from Sollers in Risk-based Monitoring is an added advantage.
March 4, 2021
Role of PV & Clinical Trials in Covid-19 Vaccine
COVID-19 pandemic has generated various challenges and opportunities across the healthcare landscape. The pandemic is shining a flashlight on how these technologies can support organizations quickly and correctly to drive complex administrative provisions, especially in the face of a massive influx of new data treatments for COVID, which are taking place worldwide with the help of Clinical Trials and Pharmacovigilance.

The volume and speed of clinical research to discover effective drugs against novel coronavirus has been exceptional. The regulations are made adjustable and convenient without any relaxation in drug safety reporting to address the unmet medical requirements.

The pharmacovigilance actions, primarily adverse event reporting despite clinical practice and clinical trials, should continue because patient safety is superior. PV system analyses collect and share drug safety data while aiming to reduce risk to patients in the shortest possible time. PV will apply to both approved drugs and under clinical trials.

Biopharmaceutical organizations and health experts are purposefully driving faster and more flexibly than they ever have before. While there is colossal urgency to scale and create these medications quickly, this cannot damage safety and efficacy.

Owing to the need to produce vaccines quickly during the COVID-19 vaccine research and production, the pharma companies and scientists overcame pharmacovigilance challenges in four major ways without compromising the quality of creating vaccines.
- Mass Data Collection
- Regulatory & Safety Reporting
- Patient Services
- Mass Manufacturing & Distribution
Providing the industry with real-time pharmacovigilance data enhances the ability to foretell and respond to safety interests as they happen, not only heightening regulatory compliance but also improving patient safety in both the short- and longer-term.

In the longer term, aiding in the business of proactive safety practices will give pharmaceutical companies the competing edge they require to see gaps and possibilities in the life sciences landscape and drive medicine innovation for the world at large.

With Sollers‘ help, anyone can exceed all the essential tools and technologies. Power your career with Clinical Trial Management and Drug Safety and Pharmacovigilance certification. Sollers College aims to help those who want to begin their career in the healthcare sector; healthcare professionals also accomplish mid-level positions with the certification program’s help.
January 25, 2021
Start your Career Advancement with Sollers
Starting a career is a time of discovery. It is also a chance to explore your strengths, understand your real interests, choose your profession, and realize what is essential to you. For that, you need to attain a proper guidance that drives to offer you the widest choice.

As one of the best education institutes in the US we support our students even if they are from the most diverse educational backgrounds. We help in obtaining their career goals for the future.

Every student at Sollers has their own story based on their background, aspirations they want to achieve, and their ideas about their career. Our industry-based career advisors with 10 to 15 years of domain related experience provide guidance to the graduates in resume and interview preparation in a small group and one-on-one sessions. What could be better than a personal meeting with experts to seek knowledge and solution? We hold events where you can listen to our experts’ experts speak about their experiences and share knowledge, ask them questions, and start building relationships even before joining the company. Increase your chances of successful employment!

We provide a reference for appropriate fields, which is value-added. Let’s build a future together! But first, to do this, you need to know about Sollers Career Guidance.

Feel the difference!

We are here to
- help in providing hands-on training in databases and systems
- help to achieve results
- hep to gain profound experience
- help for references
- help to establish necessary contacts
- help to prepare for an interview
- help to prepare resume
- help to step up your career
December 8, 2020

Types of Pharmacovigilance Softwares

In the age of rapid shift in data and analytics, the pharmacovigilance software paradigm allows the science of pharmacovigilance to advance at a fast pace.

Pharmacovigilance software database offers alerts for fast cases, follow-up cases, and reports submission to fulfill regulatory timeline compliance. Any pharmacovigilance safety database must be deposited up to date with the most advanced regulatory requirements and certified to meet international standards and business requirements. Safety databases expedite the reporting of individual and aggregate safety data to authorities and third parties and provide critical information for detecting safety signals and the ongoing evaluation of the risk-benefit profile of the company’s products.

Factors to consider include:

Costs of maintenance and Implementation
Hosting models accessibility
Previous experience
Interoperability and Compatibility

Let’s know the features of the software.

Name of the Software	Distinctive Features
Oracle Argus Safety	Oracle Argus Safety is a vast platform invented to address the complex pharmacovigilance requirements of the life science industry. Argus Safety’s advanced database helps ensure global regulatory compliance, enables sound safety decisions, and integrates safety and risk management functions. Origination of cases via case entry screens Tracking of local data items Support for e-signatures Duplicate search capabilities Local labeling decisions made against local datasheet or license Case views provided to appropriate local affiliate Pictures of core documents and global protocols such as action items on a worklist. Central staging area for evaluating submitted affiliate cases Electronic submission abilities Reporting and Querying cases taken and submitted Audit Trails
ARISg	ARISg is also one of the most employed software in Pharmacovigilance used by pharmaceutical firms.. It is used to manage crucial drug safety data worldwide. It provides all the functionality needed to manage adverse reaction requirements and adverse event reporting of several regulatory authorizations worldwide. It allows for all pharmacovigilance methods from case entry to automatic generation of resignation ready adverse event (AE) reports etc., ARISg forms a core element of an integrated pharmacovigilance and risk management system, allowing organizations to identify safety risks and monitor their products. ARISg helps advance the management of Adverse Drug reactions using its advanced automation and configurable workflow features.
AB Cube: SafetyEasy	AB Cube Safety Easy is a compliant-ready multi vigilance database. Its fully united platform of tools and functionality offers comprehensive and versatile safety data management via a straightforward, intuitive, and user-friendly interface. SafetyEasy comes with an inbuilt query and reporting functionality. It provides validated outputs designed for expedited and signal detection, case management, periodic reports. The system is presented as a cloud-based software-as-a-service (SaaS) solution, regularly updated to meet current regulatory standards and industry specifications. Defining features for AB Cube SafetyEasy are it’s easy to use integrated functionality, user interface, and ease of data movement both into and out of the database.
Clinevo Safety	Clinevo Safety is currently used by 100+ end clients and is being used to process 100k cases per year. It is an all-in-one system that provides PV Intake, Case Processing, AI, Analytics, Submissions / inbuilt AS2 Gateway, Signal Management and Safety Analytics capabilities under one platform. Clinevo Pharmacovigilance database / Drug Safety Database includes Case processing, , PV Intake,Submissions, AI & Analytics, and Safety signals It is database is built on a simplified technology stack which provides a lot of configurations and less customizations It is the best drug safety database /Pharmacovigilance database which provides end user alerts for cases nearing due dates It consists of easily configurable dynamic workflows for expedited case processing It provides powerful and actionable insights It is a user-friendly web application which can be accessed with basic internet / intranet using IE, Chrome and Firefox browsers It complies with all current and emerging regulations including 21 CFR Part 11, ANNEX 11, GxP, and GDPR. It provides transparent optimized pricing with no compromise in functionality, It provides High performance and efficiency. It is built on a secured regulatory complaint infrastructure. It works towards reduction of end user efforts through constant automation and AI capability enhancements.

While we have discussed many Softwares in Pharmacovigilance, Oracle Argus Safety is a preferred method for managing drug safety data management. Thus the knowledge of Oracle Argus Safety is quite advantageous to stay connected in the industry today.

For profound insights into the world of Pharmacovigilance, visit our Sollers website.

Want to explore a career in Drug Safety and Pharmacovigilance? Join our certification or master’s program in the Pharmacovigilance program and kick-start your career in Pharmacovigilance and get experience working in the Argus Safety database.

November 26, 2020

Why is Data Science a Turning Point for Healthcare?
As a healthcare professional, you apparently understand that digital transformation in the healthcare industry can feel overwhelming, right? Picking which emerging technologies are worth investing in and getting your skills advanced with change is often the most challenging factor. Adapting to the digital era entails a shift towards a flexible and risk-taking mindset.

Every business is sensitive to human error and forgery, similar to the healthcare enterprise. It is relentlessly undergoing paradigm shifts. The data science solutions reshape the medicine industry, uncover new insights, and turn bold ideas into reality. The possibilities for integrating data science and healthcare are expanding as the amount of data is growing faster each day, and the technologies are continually improving.

Machine learning is a new paradigm in data usage—an amalgamation of machine learning and statistics empowering the future’s clinical trial. It’s an approach already being used in other disciplines and industries and has enormous clinical research potential. Anticipate seeing a combination of statistics and machine learning powering the clinical trial of the future.

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Micro-trends, discoveries, technologies in medical sciences are shaping the healthcare sector. What are developments on the horizon at the beginning of 2020?

Here are a few tremendous transformative forces expected in the upcoming months.

At a glance
- Data Mining holds great potential in the clinical industry to identify inefficiencies and our data and analytics systematically
- AI and ML helping to lead to earlier diagnosis of the diseases
- SAS is the industry standard for analytics and data management of huge volumes of clinical data.
- Applications of machine learning methodologies in Clinical Industry
- SQL and data visualization with a tableau tool
- Technology is obtaining credibility
- Digital therapeutics are enhancing the new pills
- New players can execute healthcare patient-friendly
- Exact AI with a human touch
- Accessible care as a central need
- Improving trust in digital health
- Digital components of a shared future
Today, there is an enormous demand to train Clinical Data Science professionals, and that is why one should think of earning a Clinical data science certification.

It has a vast scope in terms of various applications in respective industries, but also the healthcare industry is facing a dearth of qualified clinical data scientists. It makes the perfect timing to grab the opportunity by joining data science classes in Sollers. Clinical data science classes would help you become a trained professional with a highly promising future.
November 20, 2020
Exciting Jobs in Drug Safety

Drug Safety has expanded considerably as a discipline over the past few years. Because of its massive prevalence in the market most of the students choose their careers in this swiftly emerging & challenging sector.

Today, many healthcare companies are inclined towards Drug Safety. Based on the level of exposure achieved, career progression in Drug Safety can lean towards line management or a more technical direction.

Let’s have a look at the trending positions in Drug Safety sector(Line Management):

Drug Safety Coordinator:

Responsible for the receipt and data entry of adverse event records following organizational standard operating procedures, internal business practices, and regulatory guidance documents to ensure compliance with worldwide safety regulations and corporate policies.

Drug Safety Associate:

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

PV Officer:

PV officers liaise closely with drug and medical organization representatives, doctors, patients, and other healthcare specialists to record drugs and other practices’ effectiveness. The data is recorded, analyzed, and processed because pharmacovigilance officers’ informed opinions will help pharmaceutical corporations enhance product safety and performance and cut down on adverse effects.

Drug Safety Scientist:

Prepare safety assessment reports and other safety documents and regulatory responses. Manage actions relating to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational products under the applicable regulatory requirements.

Gain the in-demand abilities you require to break into a new career in the Drug Safety with Sollers certification. No earlier experience is needed to get started. Tell us your goals, and we’ll match you with the right jobs.

Sollers College strives to support those who want to begin their career in the healthcare sector; healthcare professionals also attain mid-level positions with the help of the Certification program.

November 3, 2020
Global Marketing Trends of Pharmacovigilance
The pharmacovigilance demand is expected to cross USD 10,881.03 Million by 2025 at a CAGR of 14.1%. The expanding prevalence of chronic conditions is exacted to drive the increase of the global market pharmacovigilance. Growing preference towards drug personalization stimulates the global pharmacovigilance market outlook in between 2019-2025.

Rising adoption and acceptance of outsourcing services by healthcare companies will spur pharmacovigilance (PV) market growth during the upcoming years. Outsourcing dismisses the risk of market overhead costs as well as the deployment of pharmacovigilance support. Outsourcing strategy increases the cost-effectiveness and efficiency by relieving resource pressure of the manufacturing companies. Pharmacovigilance outsourcing shifting trends owing to growing benefits will accelerate to market expansion in the coming years.

Market Drivers
- Increasing the choice of outsourcing services
- Growing technological improvements
- The increasing ubiquity of chronic conditions
- Increasing expenditure on oncology medicine and research
- Massive spending by the pharmaceutical industry
- Improving drug development and drug consumption rates
- Increase in evidence of adverse drug reactions (ADRs) and medication errors
- Patent expiration of branded drugs and an increasing number of new drug developments
The demand for Drug Safety Scientists has increased with the need for professionals with Signal Detection, Risk Management, and Aggregate Report Writing experience. Pharmacovigilance is arguably one of the most challenging markets to recruit within the Life Sciences sector.

Therefore, it is not surprising that most agencies will have just one specialist looking at this area when there can be an army of recruiters working in Clinical, QA, Regulatory Affairs, etc. It is necessary to pursue certification courses. With the help of Sollers, anyone can excel with all the required tools and technologies. Power your career with Drug Safety and Pharmacovigilance certification.
October 13, 2020
Drug Safety and Pharmacovigilance: A Thriving Career Platform
Drug Safety and Pharmacovigilance radically transforming the future of the Pharmaceutical industry. The healthcare sector’s never-ending progress has resulted in modern medicines’ availability to prevent efficiently, control, and manage disease state. Renowned focus emerges for more direct involvement of patients and treatments. Despite many benefits, medicines’ adverse reactions are not uncommon, and those are associated with most newly developed drugs. Hence the Drug Safety and Pharmacovigilance field is always a front runner and plays a massive role in improving and promoting public health.

The Drug Safety and Pharmacovigilance market’s current trends are in conjunction with the demanding scope, remuneration scale, geographical landscape, and growth graph of this vertical have also been included in this report. The volume and speed of clinical research to discover effective drugs against novel coronavirus has been remarkable. The governance is made flexible and convenient without any leisure in drug safety reporting to address the unmet medical need.

It is imperative evidence that in COVID days, the pharmacovigilance activities, particularly adverse event reporting, should remain as usual as patient safety is the priority despite clinical practice or clinical trials. The susceptibility to experimental drugs with limited evidence of risk-benefit makes it numerous crucial to adopt accuracy in adverse event reporting, timely assessment, and vital safety monitoring.

The main goals of Drug Safety and Pharmacovigilance are
- Identify the risks associated with the use of medicines by the patients.
- Perform a comparative assessment of potentially beneficial and adverse effects of the drugs and help optimize the nature of service.
- Promote the effective, safe, and wise use of medicines.
- Improve awareness among patients and the general public regarding the safe use of drugs via effective communication.
Pharmacovigilance is ingrained, with several departments and rightly so, in several healthcare management areas. Drug Safety and Pharmacovigilance programs in clinical practice help healthcare professionals continuously update and remain current on the knowledge base related to medicines’ adverse outcomes.

With the growing drug consumption, the requirement for the regular monitoring of drugs has also expanded, gradually boosting the Drug Safety and Pharmacovigilance demand. Human infectious diseases are also increasing due to pervasive poverty, uncertain climate changes, and increasing urbanization, which again surge the drug consumption and drive the drug development process.

Drug Safety and Pharmacovigilance is a thriving platform for lucrative careers for life science and pharmacy graduates. We are privileged to be in a position where we can make a material difference by providing several certification programs in the Life Science sector. Students attain knowledge of adverse drug reactions, adverse events, reporting guidelines, ICSR processing, etc.
September 14, 2020

Tag: Life Science sector

Oracle Argus Safety

ARISg

AB Cube: SafetyEasy