Pharmacovigilance, Students Rosa Jones Pharmacovigilance, Students Rosa Jones

Pharmacovigilance: A Complete Guide to Pharmacovigilance and Drug Safety Training

What Is Pharmacovigilance? - Definition, Jobs, Salary, And Pharmacovigilance Certification

Pharmacovigilance

A Guide All About Pharmacovigilance


To increase your chances of getting hired or promoted, scroll below or enroll in our CCRPS Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM Course which covers drug safety and pharmacovigilance training

What is pharmacovigilance?

Pharmacovigilance Is The Study Of Two Primary Outcomes In The Pharmaceutical Industry:

Safety And Efficacy.

Essentially, it asks does a drug work and is it safe?

Pharmacovigilance is the process of monitoring the effects of drugs, both new and existing ones. This includes collecting data, analyzing it, and taking steps to prevent any negative effects. Pharmacovigilance must happen throughout the entire life cycle of a drug, from when it is first being developed to long after it has been released on the market.

What is the Aim Of Pharmacovigilance?

Pharmacovigilance is required through the entire life cycle of a drug – starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market.

Pharmacovigilance includes collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies.

It can be broken down into three main sub-specialisms:

  1. Surveillance: Surveillance is geared towards risk management and signal detection. Roles in this specialism focus analysis of drug safety information gathered from other professionals. Surveillance is responsible for creating development safety update reports (DSURs) for drugs in clinical research and periodic benefit-risk evaluation reports (PBRER) for drugs that are on the market.

  2. Operations: Operations focus on collecting and recording information during preclinical development, early clinical trials, and gathering real-world evidence (RWE) of adverse events reported by medical professionals and patients. Operations may also create standard operating procedures (SOPs), individual case study reports, and regulatory reports.

  3. Systems: Systems is concerned with the development of robust systems to store and manage data relating to pharmacovigilance. It involves keeping abreast of changing regulations and guidance in the pharmacovigilance industry and ensuring compliance at all levels of an organization.

The Qualified Person for Pharmacovigilance (QPPV) is responsible for ensuring that an organization's pharmacovigilance system meets all applicable requirements.

What is Pharmacovigilance Training?

If you’re looking to boost your career prospects in the pharmaceutical industry, drug safety training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, certification is crucial.

If you run a company and want to provide your staff with drug safety training to increase their knowledge and provide a safer working environment, our course is for you too.

We even help train Senior PVs from Fortune 500 companies to improve their efficiency and compliance.

No experience? No worries!

Our triple-accredited Advanced Pharmacovigilance and Argus Safety Certification (APVASC)TM is designed to teach you all you need to know in just 1 week!

Recognized Drug Safety Training I 180 Hours I On-Demand I Accredited I 25+ Modules I Training Compliance I Instant Enrolment I 1+Wk Certification I

What do Pharmacovigilance Officers do?

The exact nature of each role varies, but in essence, Pharmacovigilance Officers (PVs) collect adverse event data on drugs (Phase 4) to analyse and create usage warnings for the drug.

Some roles insist on physicians, nurses, or those with a Master of Science degree. A Master’s in pharmacovigilance is your best route into the industry – but that takes up to 2 years and is very expensive.

Your quicker route into the industry is with a drug safety accreditation.

Please note: A minimum of an associate degree is required to take any training course, including ours.

How To Get Into Pharmacovigilance

The CCRPS pharmacovigilance certification to provide advanced training for entry level pharmacovigilance to ensure you are fully prepared for a career in drug safety monitoring. We are a non-profit organization dedicated to providing advanced pharmacovigilance training to students at all stages of their careers.

The courses provide you with theory and practical-based learning in pharmacovigilance and give you vital industry experience.

Our pharmacovigilance training courses meet
WHO-ISoP and FDA guidelines and are accredited by the ACCRE and other recognized accreditation boards.

You’ll learn the basics of pharmacovigilance, why it’s necessary, its history, and how to find career opportunities within the industry.

You’ll look at different methodologies, pharmacovigilance regulation, pharmacovigilance audit and risk management, and vaccine pharmacovigilance.

You’ll also discover where to find further information to enhance your pharmacovigilance knowledge and study individual case reports to get to grips with the finer details of the subject.

At the end of the course, you will receive your certification. Then you’re ready to set out on your pharmacovigilance career.

After achieving your certification, you’ll open up a world of opportunities in pharmacovigilance and be qualified for entry-level roles including, but not limited to the following Drug Safety Jobs:

Pharmacovigilance Jobs

Pharmacovigilance Jobs Entry Level

Remote Pharmacovigilance Jobs

18,000 Pharmacovigilance Jobs (always include a SPECIFIC cover letter for all jobs and follow up at least twice by email if you do not hear back to show interest to every single job).

  • Drug safety or Pharmacovigilance scientist (specialist or associate)

  • Drug safety or PV manager

  • Safety or PV reviewer

  • Pharmacovigilance Quality Compliance

  • Clinical Quality specialist

  • Medical Safety scientist/specialist/reviewer

  • Local safety officer

  • Clinical trial project safety associate (reviewer or specialist)

  • MedDRA coder

  • Pharmacovigilance safety and analytics reporting analyst/specialist/associate

  • Pharmacovigilance Auditor or PV Inspection readiness officer

    • Safety or Pharmacovigilance Physician (medical director, MD/MBBS, IMG)

    • Safety Compliance Writer

    • Good PV Practices manager

    • GCP specialist

    • Pharmacovigilance vendor

    • Case processing specialist

    • Clinical trial case processing safety specialist

    • Post-marketing case processing safety specialist

    • Epidemiology safety associate (MPH) • Risk management manager
    • Signal management specialist
    • Periodic reporting specialist

    • Regulatory affairs safety specialist

    You’ll also be qualified to act as an onsite safety representative for the duration of a given contract.

Pharmacovigilance Salary

The pandemic has demonstrated just how vital the pharmaceutical industry is to the smooth running of the country and the economy. And with the average entry-level salary in pharmacovigilance in the region of $69,000, it provides a unique opportunity to do your duty and be well-rewarded.

Once you are experienced in
pharmacovigilance, you can expect to command a salary of around $114,000.

And after 3-10 years in the industry, you can expect to earn $136,000. Based on salary, the US is the best country for pharmacovigilance jobs although pharmacovigilance is paid well globally as well.

We have trained over 1,800 clinical research and pharmacovigilance professionals and cover global clinical safety and pharmacovigilance as well as argus safety data base certification in our online, on-demand course. Our drug safety training is provided online and can be completed in less than a week. This is a great alternative to a diploma course in pharmacovigilance as you can finish quickly and still get an advanced level of understanding under your belt.

You can speak with our enrollment advisors for assistance in pricing and scholarship. Completed certification helps demonstrate your interest and knowledge to employers.

A career in pharmacovigilance is rewarding both personally and financially.

But like all new career paths, it can be difficult to gain experience or demonstrate your commitment from the outside. Achieving an accredited PV certification shows potential employers that you are serious about a career in the industry. It proves that you have the required knowledge and understanding of pharmacovigilance to add value to their organization.

For further details, call and speak to one of our 24/7 enrollment representatives through the orange chat box.

Good pharmacovigilance practice - ICH GCP guidelines for pharmacovigilance

Pharmacovigilance certification

Online Pharmacovigilance Training Course

Pharmacovigilance Certification

by CCRPS pharmacovigilance training institute is a globally-accepted, accredited Online Pharmacovigilance Training Course

Fundamentals Of Global Pharmacovigilance

Introduction to Drug Safety and PV FREE PREVIEW

Key PV Terminology (Side Effect, Drug Safety, and Risk Terms) FREE PREVIEW

International Regulatory Requirements and Guidelines Overview FREE PREVIEW

Pharmacovigilance Quiz

Regional Regulatory Requirements (FDA, EMA, Japan, China) FREE PREVIEW

Postmarketing Surveillance (PMS) and Safety Management FREE PREVIEW

GVP - Pharmacovigilance Abbreviations Advanced Review of Adverse Event Reporting

Advanced Review Of Pharmacovigilance

Advanced Practice of Pharmacovigilance Pharmacovigilance Quiz

Additional Encompassing and Confusing Terms in Pharmacovigilance

MedDRA (Hierarchy, Searching, Terms, Exporting, Assessing, Important Medical Events)

Pharmacovigilance Quiz
Need for Pharmacovigilance
The History of Pharmacovigilance FREE PREVIEW Roles in Pharmacovigilance Pharmacovigilance Quiz
Key Stakeholders in Pharmacovigilance Pharmacovigilance Quiz

Post-marketing AE Processing and Reporting(ICSR, Case Processing, Narrative Writing, & International Aggregate Reporting)

Pharmacovigilance Quiz

Signal Detection (Detection, Validation, Prioritization, and Action)

Pharmacovigilance Quiz
Risk Assessment, Plan, and Management Pharmacovigilance Quiz

Vaccine Surveillance - COVID-19 Updated (AEFI, Vaccinology, AESI, AVSS, Communication, and Case Studies)

Post-authorization/Post-marketing Regulations in Pharmacovigilance

Argus Safety Database Certification

Argus Safety Database Certification Part 1 (Into and Video Demos)

Argus Safety Database Certification Part 2 Argus Safety Database Certification Part 3 Argus Safety Database Certification Part 4 Argus Safety Database Certification Part 5 Argus Safety Database Certification Part 6 Oracle Argus Safety User Guide

Resources

International Pharmacovigilance Initiatives and Guidelines - EMA

DIA Safety and Pharmacovigilance Competencies

Pharmacovigilance Career Resources

WHO-ISoP Pharmacovigilance Resources

E2E-Pharmacovigilance Planning

GVP XVI Addendum: Educational Materials

GVP Module I-IV PV Systems, PSMF, Inspections & Audits

GVP I: Pharmacovigilance Systems

GVP VIII: Post-authorisation Safety Studies

GVP III: Pharmacovigilance Inspections

GVP IX Addendum: Methodological aspects

GVP V: Risk management systems

GVP IX: Signal management-

GVP VIII Addendum: Requirements- recommendations_en-1

GVP XV: Safety Communication

GVP XVI: Risk-minimization measures

GVP II: Pharmacovigilance System Master File

GVP VI: Duplicate Management

GVI VI: Pharmacovigilance Audits

GVP X: Additional Monitoring

GVP VII: Periodic Safety Update Report

GVP VI: Collection, management, and submission of reports

Pharmacovigilance Definition

Investigational product (IP): Any drug, device, therapy, or intervention after Phase I trial

Event: Any undesirable outcome (i.e. undesired laboratory finding, symptom, or disease)

Adverse event/experience (AE): Any related OR unrelated event occurring during use of IP

Adverse drug reaction/effect (ADR/ADE): AE that is related to product

Serious Adverse Event (SAE): AE that causes death, disability, incapacity, is life- threatening, requires/prolongs hospitalization, or leads to birth defect

Unexpected Adverse Event (UAE): AE that is not previously listed on product information

Unexpected Adverse Reaction: ADR that is not previously listed on product information

Suspected Unexpected Serious Adverse Reaction (SUSAR): Serious + Unexpected + ADR

Causality assessment: Review of drug (i.e. pharmacology, pathophysiology, time overlap of event and IP administration, dechallenge and rechallenge, confounding patient-specific disease manifestations or other medications, and other explanations) to determine if certain, probable/likely, possible, unlikely, conditional/unclassified, unassessable/unclassifiable.

Dechallenge vs. Rechallenge: Causality assessed by measuring AE outcomes when withdrawing vs. re-administering IP

Causal relationship: Determined to be certain, probable/likely, or possible (AE + Causal -> ADR)

Seriousness: based on outcome + guide to reporting obligations (i.e. death SAE -> report in 3 days) mnemonic: seriOOusness = OutcOme

• Severity: based on intensity (mild, moderate, severe) regardless of medical outcome (i.e. severe headache -> not serious) mnemonic: severiTTy = InTensiTy

• Temporal relationship: Positive if AE timing within use or half-life of drug (positive, suggestive, compatible, weak, negative)

• Signal: Event information after drug approved providing new adverse or beneficial knowledge about IP that justifies further studying (PMS = signal detection, validation, confirmation, analysis, & assessment and recommendation for action)

• Identified risk: Event noticed in signal evaluation known to be related/listed on product information

• Potential risk: Event noticed in signal evaluation scientifically related to product but not listed on product information

• Important risk/Safety concern: Identified or potential risk that can impact risk-benefit ratio

• Risk-benefit ratio: Ratio of IP’s positive therapeutic effect to risks of safety/efficacy

• Summary of product characteristics (SmPC/SPC): guide for doctors to use IP

Good Pharmacovigilance Practice - ICH GCP guidelines for pharmacovigilance

Global Pharmacovigilance laws and regulations - IAOCR Directory

Local Pharmacovigilance Regulatory Bodies

  • Australia – Therapeutic Goods Administration (TGA)

    • New Zealand – MEDSAFE

    • North America

    • Canada – Health Canada ~2%

    • USA* – FDA: Food and Drug Administration ~33%

    • Central/South America

    • Argentina – ANMAT

    • Brazil – Agencia Nacional de Vigilancia Sanitaria (ANVISA)

    • Chile – Instituto de Salud Publico (ISP)

    • Columbia – Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)

    • Costa Rica – Ministerio de Salud

    • Cuba – CECMED

    • Dominican Republic – Dirección General de Drogas y Farmacias

    • Jamaica – Ministry of Health

    • Mexico – Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

    • Paraguay – Ministro de Salud Pública y Bienestar Social

    • Peru – Ministerio de Salud

    • Uruguay – Ministerio de Salud Publica

    • European Union* – EMA: European Medicines Agency ~17%

    • Armenia – Scientific Centre of Drug and Medical Technology Expertise

    • Austria – Agency for Health and Food Safety (AGES)

    • Belgium – Federal Agency for Medicines and Health Products

    • Bulgaria – Bulgarian Drug Agency

    • Croatia – Agency for Medicinal Products and Medical Devices of Croatia

    • Cyprus – Ministry of Health

    • Czech Republic – State Institute for Drug Control

    • Denmark – Danish Medicines Agency

    • Estonia – State Agency of Medicines

    • Finland – Finish Medicines Agency

    • France – Agence Nationale de Sécurité du Medicament et des Produits de Santé

    • Germany – Federal Institute for Drugs and Medical Devices

    • Georgia – Regulation Agency for Medical and Pharmaceutical Activities

    • Greece – National Organisation for Medicines

    • Hungary – National Institute of Pharmacy

    • Iceland – Icelandic Medicines Agency

    • Ireland – Irish Medicines Board

    • Italy – National Institute of Health

    • Lithuania – State Medicines Control Agency

    • Luxembourg – Ministry of Health

    • Malta – Maltese Medicines Authority

      Moldova – Medicines Agency

    • Netherlands – Medicines Evaluation Board

    • Norway – Norwegian Medicines Agency

    • Poland – The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

    • Portugal – National Authority of Medicines and Health Products

    • Romania – National Medicines Agency

    • Russia – Ministry of Health of the Russian Federation• Serbia – Medicines and Medical Devices Agency of Serbia

      • Slovakia – State Institute for Drug Control • Slovenia – Ministry of Health
      • Spain – Spanish Medicines Agency
      • Sweden – Medical Products Agency

      • Switzerland – Swiss Agency for Therapeutic Products

      • Ukraine – Ministry of Health

      • United Kingdom – Medicines and Healthcare Regulatory Agency (MHRA)

      • Bahrain – I-SEHA

      • Egypt – Ministry of Health

      • Iran – Ministry of Health

      • Israel – Ministry of Health

      • Jordan – Jordan Food and Drug Administration

      • Lebanon – Ministry of Public Health

      • Saudi Arabia – Saudi Food and Drug Authority

      • United Arab Emirates – Ministry of Health

      • Bangladesh – Directorate General of Drug Administration (DGDA)

      • Bhutan – Drug Regulatory Authority

      • China* – CFDA/NMPA: State Food and Drug Administration

      • India – Central Drug Standards Control Organization (CDSCO)

      • Indonesia – POM (Pengawas Obat dan Makanan)

      • JAPAN* – PMDA: Ministry of Health, Labour and Welfare ~12%

      • Korea (South) – Korean Food and Drug Administration (KFDA) ~1%

      • Laos – Food and Drug Department

      • Malaysia – Ministry of Health (MOH)

      • Nepal – Department of Drug Administration

      • Philippines – Department of Health (DOH)

      • Singapore – Health Sciences Authority (HSA)

      • Sri Lanka – Ministry of Health (MOH)

      • Taiwan (Republic of China) – Taiwan Food and Drug Administration (TFDA)

      • Thailand – Food and Drug Administration of Thailand

      • Vietnam – Drug Administration of Vietnam

      • Algeria – Ministry of Health and Population • Botswana – Ministry of Health (MOH)
      • Burkina Faso – Le Ministère de la Santé

      • Ghana – Food and Drugs Authority

      • Kenya – Pharmacy and Poisons Board

      • Morocco – Ministry of Health

      • Nigeria – National Agency for Food and Drug Administration and Control

      • Rwanda – Ministry of Health

      • Senegal – Ministère de la Santé et de l’Action Sociale

      • South Africa – Medicines Control Council (MCC)

      • Swaziland – Ministry of Health

      • Tanzania – Tanzania Food and Drug Authority (TFDA)

      • Uganda – National Drug Authority

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Introduction to Pharmacovigilance

Fig 1: Drug safety and pharmacovigilance 

Fig 1: Drug safety and pharmacovigilance 

Introduction to pharmacovigilance

 

According to the world health organization, "pharmacovigilance also know as drug safety, is the pharmacological science related to the collection, detection, assessment, monitoring, and prevention of adverse effects of the pharmaceutical drugs"

Aims of pharmacy vigilance are the following

Fig 2: why do we need pharmacovigilance 

Fig 2: why do we need pharmacovigilance 

• Improve patient care about the drugs and keep the patient safe from adverse effects of drug

• Pharmacovigilance keep track of any drastic effect of the drug

• To research the efficacy of the drug and check effects of drugs during trials to the pharmacy and then keep monitoring their effects for many years

• Bring improvement in the public healthcare system by a thorough assessment of drugs effect on the body

• Promote training and knowledge about this field of medicine

• To know the mechanisms of the drug inside the human body

• To encourage safe and rational use of medicines

Fig 4: Phases of drug development 

Fig 4: Phases of drug development 


Objectives of pharmacovigilance

• To properly detect the unknown adverse effect and drug interaction

• Distribution of information about the adverse effect of drugs and drug interactions so that they occur less frequently

• Timely correction of therapeutic errors

• Reevaluation of the risk-benefit balance of medicine, so we can effectively use those drugs for a patient having more benefits and fewer side effects

• Identifications of mechanisms that cause adverse effects of drugs

Fig 3: Stakeholders in pharmacovigilance 

Fig 3: Stakeholders in pharmacovigilance 

There are mainly four stake holders in pharmacovigilance

1- Patient

2- Doctor or pharmacist

3- Marketing authorization holder

4- Regulators such as authorities, committee

Steps of pharmacovigilance

introduction to pharmacovigilance

Fig 5: PV workflow 

Step 1 is the collection of reports about the adverse effect and all adverse reactions of the drugs. All adverse reactions, including serious and unexpected effects, are subjected to expedited reporting.

Step 2 involves receiving the cumulative reports regarding the safety of drugs and sending those reports to all the regulatory authorities.

Step 3 The process of determining the specific adverse effect associated with a specified drug and then comparing this drug with another drug having a similar worse effect.

Step 4 Management of adverse effects of the drugs. Receive information regarding the harmful effects on patients or population and seek a method to minimize these effects.

Pharmacovigilance regulations:

International Conference of Harmonization consists of authorities from India, Europe, and Japan with representatives of the correlating industries, health organization, and WHO as an observer. This conference provides guidelines regarding pharmacovigilance and good drugs. There is stepwise development of instructions. At step four, there is a consensus internationally, and at step 5, an agreement for regulators to introduce the guidelines to legislation.

The principal role of pharmacovigilance is to ensure the safer usage of drugs. But the pressure is increasing on this field to analyze data about the adverse effect, monitor risk more broadly, and accurately reports patient events.

 What information should we report to higher authorities?

• Any information on adverse drug reaction

• lack of efficacy of the drug

• Even when there is no observed adverse effect, report abuse of the drug, effect of overdose, and about drug administration during pregnancy



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What is the Role of Pharmacovigilance in Clinical Research

What is Pharmacovigilance?

Drugs are an integral part of healthcare. New medications are constantly developed and tested by pharmaceutical companies to be put on the market. However, according to the American Society of Pharmacovigilance, adverse drug events annually account for: 1 million emergency department visits, 2.2 million hospital admissions, 3.5 million physician office visits, and $136 billion in U.S. health care costs. Thus, it is paramount that these drugs are as safe they can be.

Pharmacovigilance (PV), or drug safety, is the study of a drug’s adverse reactions. PV professionals work in varying specialties to ensure that a drug is safe and tested before it can be consumed by the masses.

Why is PV Important?

A drug needs to be approved by the appropriate regulatory body before going on the market. In the U.S., the FDA determines what drugs are ready for the market. Before a drug can apply for FDA approval, it must undergo three phases of clinical trials. Every proceeding phase involves more people and more risk. Thus, it is important for the clinical research team and pharmaceutical company to be sure that a drug is safe before proceeding with the next phase.

What Roles are in PV?

In clinical research, PV operations work with the clinical research team to collect information on a drug’s SAE and ADR. SAE is a serious adverse event. They can be lethal or cause disabilities in the patient or induce birth defects. On the other hand, ADR is an adverse drug reaction, which is a milder adverse reaction to a drug. They include conditions like headaches, nausea, or fatigue.

In addition to data collection, operations are responsible for creating standard operating procedures (SOPs), as well as individual case study reports, literature screening, and regulatory expedited reporting on Suspected unexpected serious adverse reactions (SUSARs), or unknown as unexpected serious adverse reactions, after the drugs are on the market. Those interested in a deeper dive into standard operating procedures and case studies might consider exploring the ICH-GCP course.

The safety data collected by the operations division is maintained by those in the PV systems. They ensure that the data is organized and accessible to research collaborators. The systems team is always working to improve and maintain the vast data, since field regulations and expectations are always changing.

The safety data is then handed to the PV surveillance team. PV surveillance analyzes the safety data and then compiles their analysis into development safety update reports (DSURs). This report determines whether or not the drug is safe enough to move on to the next phase of clinical research. At the end of the third phase, if the drug is safe enough, the PV will submit the drug for FDA approval. Professionals aiming to oversee such critical roles in drug safety might be interested in the Advanced Clinical Research Project Manager Certification.


How Do I Start?

The PV department needs and recruits diverse talents to ensure that a drug is safe. If you can see yourself in one of these positions, then you should absolutely consider a career in PV. CCRPS recently launched our pharmacovigilance course to help aspiring professionals learn about the field and stand out in front of employers. If you want to learn more about pharmacovigilance, please visit our website at CCRPS.Org and chec.

Take courses from CCRPS and learn more on how to become a clinical research professional.

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