This blog features:
- All about important aspects of overview in pharmacovigilance
- Growth index and future of pharmacovigilance
- Career opportunities within pharmacovigilance
Table of Contents
- Introduction
- Eligible for a Pharmacovigilance Career
- Understanding the Pharmacovigilance Process
- Objectives of Pharmacovigilance
- Is this process really mandate?
- Phases of pharmacoviglance
- Controlling and regulating bodies of pharmacovigilance
- Outcomes of pharmacovigilance process
- Partners in pharmacovigilance
- Internal aspects of pharmacovigilance team
- Future of pharmacovigilance
- Conclusion
Introduction
This extensive blog seeks to fulfill its primary objective of explaining essential concepts for beginners, distilling knowledge into concise and valuable points to consider.
Awareness to pharmacovigilance
In recent times, there has been increased awareness about pharmacovigilance, yet the public still lacks in reporting adverse events. However, professionals and recent graduates show a strong interest in pursuing careers in pharmacovigilance.
Eligible for a pharmacovigilance career
- Pharmacist
- Physicians
- Dental surgeons
- Other HCP
Pursuance a career in pharmacovigilance
In the past decade, numerous recent graduates have shown a strong interest in pursuing careers in pharmacovigilance.
However, many of them struggle to find the right resources or guidance, leading to confusion at this stage.
📢 If you’re still undecided and caught in the middle of your decision-making process, consider reading our comprehensive article on choosing between pharmacovigilance and clinical research.
Understanding the pharmacovigilance process
For those beginners in the field of health sciences, grasping the pharmacovigilance process might spark curiosity.
Pharmacovigilance involves a structured sequence of activities, beginning with the collection, coding, and submission of data to health authorities.
But what exactly constitutes this data?
It comprises information gathered from studies and reports of adverse events, meticulously organized, coded, and assessed for causality.
The process unfolds through distinct stages: Collection, Detection, Assessment, and Monitoring.
Ultimately, the overarching goal is to safeguard the public by preempting adverse reactions triggered by pharmaceuticals.
Objectives of pharmacovigilance
- To guarantee drug safety
- Collecting data from health practitioners
- Systematically monitoring populations
- Reviewing health statistics and drug utilization data
- Conducting effective analysis of input data
Understanding Drug Safety Profiles
Every medication on the market carries its own set of potential side effects, which are often unavoidable.
However, to prioritize public safety, it’s imperative to continuously monitor drug profiles, identify adverse events, minimize drug abuse, curb the circulation of counterfeit and fake drugs, and raise awareness among the public.
Risk-benefit profile
One of the main roles of pharmacovigilance is analyzing the risks and benefits of medicines.
Medicines can both heal and harm. While they certainly have the power to cure, they also carry significant risks. Therefore, in pharmacovigilance, it’s crucial to monitor and assess both the benefits and risks associated with medicines.
This helps reduce risks and identify ways to enhance benefits, ultimately ensuring public safety.
“The whole process in a system is a journey of continuous improvement, where understanding evolves, challenges are met with solutions, and growth is nurtured through innovation and collaboration.”
Is this process really mandate?
Yes, this process is indeed mandated. It became necessary after tragic events in history, like the thalidomide incident, which led to the “Drug Efficacy Amendments” (Kefauver–Harris Amendment) in 1962.
Even before that incident, the USFDA showed concern about the safety of medicines as early as 1952.
Now, pharmacovigilance is required for several reasons:
- It’s mandated by health authorities to ensure drug safety.
- It helps keep records of a drug’s safety profile.
- Professional interest in pharmacovigilance grew over time, leading to the establishment of organizations like the International Society of Pharmacoepidemiology (ISPE) and the European Society of Pharmacovigilance (later known as ISoP).
In simpler terms, a meeting held by the World Health Organization (WHO) in 1971 had some important outcomes:
- They suggested setting up national centers to monitor drugs.
- They created guidelines to follow.
- They figured out how these national centers could help the international system.
Need for pharmacovigilance
Pharmacovigilance is needed in these situations:
- Where the new drug introduced in to the market
- It was envisaged that the time necessary to recognize that a drug produces an adverse reaction might be reduced
- To determine drug safety problems
- Necessary for public health safety
- Adding new safety warnings and precautions
- New dosing guidelines
Phases of pharmacoviglance
- Pre-clinical
- Clinical
- Post-marketing
Products covered under pharmacovigilance
- Medicines (Humans and Animals)
- Herbals
- Biological(s)
- Medical devices
- Blood products
- Vaccines
- Traditional and complementary
Controlling and regulating bodies of pharmacovigilance
Different authorities oversee and control the pharmacovigilance process, and their responsibilities vary depending on the country. Generally, in the large context these overseeing bodies include:
- WHO
- CIOMS (To learn more about the contribution of CIOMS within pharmacovigilance)
- ICH (To learn more about understanding the nuances of ICH guidelines)
- UMC
- National Centers for Pharmacovigilance
- Drug Regulatory Agencies
Timelines for regulatory submission
Every report of adverse events must be submitted to local regulatory bodies, and there are specific timelines for this based on the region.
These timelines can vary, such as 3, 7, 15, or 90 days, depending on case severity and the requirements set by local regulatory authorities and internal requirements
Outcomes of pharmacovigilance process
Pharmacovigilance guides the healthcare experience toward positive clinical goals with minimal adverse drug reactions.
As the World Health Organization (WHO) notes, “Good pharmacovigilance practice can generate the evidence that will inspire public confidence and trust.”
Many people have a role to play in pharmacovigilance, including researchers, physicians who are writing the prescriptions, pharmacists, patients, and their family members or caregivers.
Partners in Pharmacovigilance
- Hospitals and Academic Institutions
- Healthcare Professionals
- Patients
- Other Stakeholders Including Media, Reporters, Consumers, Advocacy Groups, and Legal Representatives
- Healthcare providers within and outside the facility
- Regulatory bodies
How does pharmacovigilance affect a pharmaceutical product?
Pharmacovigilance regulations are crucial for pharmaceutical companies to maintain authorization and commercialization of their products.
Compliance with these regulations helps enhance public safety by addressing myths about medications and ensuring transparency in reporting adverse events. Companies found withholding or manipulating data face severe penalties.
The primary goal of pharmacovigilance is to reduce risks and enhance overall safety, making it essential for the pharmaceutical industry.
Why drug regulation is important?
- Approval of new medicines
- Regulating clinical trials
- Developing lines of communication between all parties with an interest in drug safety
Why need of Pharmacovigilance in drug regulation?
- To promote public confidence in Medicines
- Monitoring safety issues in everyday practice
- Ensuring ongoing safety of medicinal products
- Great supportive of proper drug regulations
- It will help the extend the limitation of pre-marketing study in terms of drug safety
- Identifying mistakes carried out by patient as well as pharmaceutical companies
- Identify counterfeit and falsified medicines in the market
- Supporting immunisation programs
Internal aspects of pharmacovigilance team
- Case processing:
- ICSR case processing
- Literature case processing
- Quality
- Medical review
- Signal detection
- Aggregate report writing:
- PSUR
- PBRER
- DSUR
- Qualified person for pharmacovigilance
- Local safety officer
- Risk management
📢 Click the link here to explore in detail about workflow of case processing within pharmacovigilance.
Hierarchy of PV team
The pharmacovigilance team operates on a hierarchical basis, meaning that individuals have different responsibilities, each with their own specific tasks.
Associate->Analyst->Scientist->Team lead->Floor manager->Site lead->Operations head
What is your entry level to pursue a career in pharmacovigilance?
In general, the entry level position in pharmacovigilance is as an associate, and this is determined by your qualifications.
For example, if you are a graduate in Allied Health Sciences or Dentistry, your entry level position would typically be as an associate.
If you hold an MBBS and MD in qualification, your entry level position would likely be as a Medical Reviewer.
Future of pharmacovigilance
Growth in technical aspects
In terms of technically the world is growing in the last decades never imagined. Meanwhile within pharmacovigilance industry also there are plenety of changes happening to ease the process. But in terms of handing the data safety there are some limitations that may possible.
Growth of pharmacovigilance industry
The pharmacovigilance market, valued at USD 7.42 billion in 2023, is expected to experience exponential growth over the next decade.
Projections indicate it will increase from USD 8.32 billion in 2024 to USD 23.45 billion by 2032, reflecting a robust compound annual growth rate (CAGR) of 13.8% during the forecast period.
The pharmacovigilance market is poised for exponential growth over the next decade without question.
📢 Source: https://www.fortunebusinessinsights.com/pharmacovigilance-pv-market-102746
PV: Future career pursuance
Since we are the HCPs, many people now looking forward the growth of pharmacovigilance industry and having a big desire in pursuing a career in pharmacoviglance.
If you ask me, can that be a right choice?
Yes definiely for sure, but keep one thing in mind. The industry will grow exponentially regardless of economic obstacles. But in particular during those time the companies suffer like other industries. So you might see some ups and downs.
Conclusion
From this write-up, you may gained a solid understanding of pharmacovigilance, including where to begin and what career growth in this field entails.
If there are any crucial aspects we’ve missed, please let us know in the comments. Additionally, feel free to share your recommendations so far.
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