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Pharmacovigilance Training Covers ✓Daily class recordings ✓Pharmacovigilance Material ✓Real-time Project ✓Life Time Access to Course ✓Pharmacovigilance Project ✓Pharmacovigilance Job Support ✓Resume ✓Mock Interview
What Is Pharmacovigilance Training?
Pharmacovigilance training refers to educational programs designed to teach professionals about the processes, principles, and practices involved in pharmacovigilance. Pharmacovigilance is the science and practice of monitoring, detecting, assessing, and preventing adverse effects or other drug-related problems associated with the use of pharmaceutical products. It plays a critical role in ensuring patient safety and promoting public health.
|Course Name||Pharmacovigilance Course|
|Duration||45 days / 1 Hr per day|
|Training Days||Monday to Friday|
|Live Class Recordings||Access Provided|
|Materials||Life Time Access|
|Software||Life Time Access|
|Resume Preparation||Included In The Course|
|Interview Preparation||Q&A Will Be Provided|
Overview of Pharmacovigilance
Medicines are chemicals or compounds used to cure, decrease or prevent disease, ease symptoms or help in the diagnosis of illness. Consuming a medicine is equivalent to consume a risk, because no medicine is absolutely safe and all pose some health risks. These risks are mild in most cases but have the potential to cause disability or even death. The decision whether medicine can be taken or not depends on benefits and risks ratio. The product will be available in market if the benefits associated with medicine outweigh the risk. Hence drug safety monitoring and risk management are vital for manufacturers and regulatory authorities.
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Pharmacovigilance also known as drug safety, is the process that make sure the medicines are safe for their intended use, which starts at drug development phase and continues through out life cycle of the product.
As per world health organization (WHO), Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
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Table of contents
- What Is Pharmacovigilance Training?
- Overview of Pharmacovigilance
- Enroll For A Free Demo
- Pharmacovigilance Training Covers
- Pharmacovigilance Jobs Eligibility
- Pharmacovigilance Job Titles
- Pharmacovigilance Job Organizations
- Pharmacovigilance Jobs Salaries In Different Countries
- CROs That Offer Pharmacovigilance Jobs
- SAS Or Pharmacovigilance Which One Is Better For Career
- Course Highlights
- Students Testimonials on pharmacovigilance Course
- Pharmacovigilance FAQs
Pharmacovigilance Training Covers
Pharmacovigilance training typically covers various aspects of drug safety, including:
1. The fundamentals of pharmacovigilance: This includes understanding the history, objectives, and importance of pharmacovigilance in the pharmaceutical industry and public health.
2. Adverse event reporting: Training in the identification, documentation, and reporting of adverse events, as well as understanding the various reporting systems and regulatory requirements.
3. Signal detection and data mining: Learning how to analyze and interpret safety data to identify potential safety signals or trends, and understanding the methodologies and statistical tools used in signal detection.
4. Risk management and mitigation: Gaining knowledge about the development and implementation of risk management plans to minimize the potential risks associated with pharmaceutical products.
5. Regulatory frameworks and guidelines: Understanding the global regulatory landscape and guidelines governing pharmacovigilance, such as those issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (FDA).
6. Quality management and compliance: Learning about the processes and systems required to ensure quality and compliance in pharmacovigilance operations, including audits and inspections. Pharmacovigilance training programs are designed for professionals working in the pharmaceutical industry, clinical research, regulatory affairs, and other related fields. They may be offered as online courses, in-person workshops, or certificate programs, and can cater to various levels of expertise, from beginners to experienced professionals. By completing pharmacovigilance training, individuals can enhance their knowledge and skills, stay up-to-date with the latest developments in drug safety, and advance their careers in this vital field.
Pharmacovigilance Jobs Eligibility
The eligibility criteria for pharmacovigilance jobs can vary depending on the specific role, the organization, and the country in which the job is located. However, some general qualifications and skills that are commonly required for pharmacovigilance positions include:
1. Educational Background:
- A bachelor's degree in life sciences, pharmacy, nursing, medicine, or a related field is typically required for entry-level positions in pharmacovigilance.
- For more specialized roles or senior positions, a master's degree or a Ph.D. in a relevant field may be preferred or required.
- Some positions may require additional certifications or diplomas in pharmacovigilance or clinical research.
2. Work Experience:
- For entry-level positions, prior experience in pharmacovigilance may not be necessary. However, experience in clinical research, pharmaceuticals, or healthcare may be advantageous.
- For more senior roles, a certain number of years of experience in pharmacovigilance, drug safety, or related fields is often required.
3. Skills and Competencies:
- Strong knowledge of pharmacovigilance principles and practices.
- Familiarity with global regulatory guidelines and requirements related to drug safety (e.g., FDA, EMA, ICH, WHO).
- Proficiency in using pharmacovigilance databases and software.
- Excellent communication and interpersonal skills, as pharmacovigilance professionals often work in cross-functional teams and need to communicate effectively with various stakeholders.
- Analytical and critical thinking abilities to assess and interpret safety data and identify potential safety signals.
- Attention to detail and strong organizational skills to manage large amounts of data and documentation.
- Ability to work independently and as part of a team. It is important to note that specific requirements may vary between organizations and job postings. Therefore, it is crucial to carefully review the job description and requirements for each position to determine your eligibility. Additionally, completing pharmacovigilance training or obtaining certifications can improve your chances of securing a job in the field.
Pharmacovigilance Job Titles
Pharmacovigilance encompasses a variety of job roles within the pharmaceutical, biotechnology, and clinical research industries. Job titles in pharmacovigilance can vary depending on the organization, but some common positions include:
1. Pharmacovigilance Associate or Drug Safety Associate: Entry-level role responsible for case processing, data entry, and reporting of adverse events.
2. Pharmacovigilance Scientist or Drug Safety Scientist: A more specialized role that involves signal detection, data analysis, and risk assessment of drug safety data.
3. Pharmacovigilance Medical Writer: Responsible for preparing safety documents, such as periodic safety update reports (PSURs), risk management plans (RMPs), and other regulatory submissions.
4. Pharmacovigilance Quality Specialist or Auditor: Ensures compliance with global regulations and guidelines, and conducts audits and inspections of pharmacovigilance systems and processes.
5. Pharmacovigilance Project Manager or Coordinator: Manages and coordinates pharmacovigilance activities across various projects, ensuring timelines and objectives are met.
6. Pharmacovigilance Officer or Compliance Officer: Ensures that the organization adheres to regulatory requirements, and is responsible for managing interactions with regulatory authorities.
7. Senior Pharmacovigilance Scientist or Senior Drug Safety Scientist: A more experienced role that involves advanced signal detection and risk management activities, as well as mentoring and guiding junior team members.
8. Pharmacovigilance Manager or Drug Safety Manager: Oversees the daily operations of the pharmacovigilance department and manages a team of pharmacovigilance professionals.
9. Pharmacovigilance Director or Drug Safety Director: Provides strategic leadership and direction for the organization's pharmacovigilance activities and ensures compliance with global regulations and guidelines.
10. Pharmacovigilance Consultant: Provides expert advice and guidance to organizations on pharmacovigilance practices, regulatory requirements, and risk management strategies.
These are just a few examples of the many job titles you might encounter in the field of pharmacovigilance. The specific roles and responsibilities associated with each title can vary depending on the organization and the scope of the position.
Pharmacovigilance Job Organizations
Organizations involved in pharmacovigilance activities span across various sectors within the pharmaceutical, biotechnology, and clinical research industries. Some types of organizations that offer pharmacovigilance job opportunities include:
1. Pharmaceutical and biotechnology companies: These organizations develop and market medicinal products, and they have in-house pharmacovigilance departments responsible for monitoring the safety of their products throughout their lifecycle.
2. Contract Research Organizations (CROs): CROs provide outsourced research and development services to the pharmaceutical and biotechnology industries, including pharmacovigilance services. They often employ pharmacovigilance professionals to manage drug safety activities on behalf of their clients.
3. Regulatory agencies: National and international regulatory bodies, such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO), have pharmacovigilance departments that monitor drug safety and regulate the industry. Pharmacovigilance professionals working for regulatory agencies are responsible for reviewing safety data submitted by companies and ensuring compliance with relevant guidelines and regulations.
4. Clinical research organizations and academic institutions: Organizations involved in clinical research, including academic research centers and hospitals, may employ pharmacovigilance professionals to monitor the safety of investigational products during clinical trials.
5. Consultancy firms: Firms specializing in pharmaceutical consulting often have pharmacovigilance experts who provide guidance and support to clients on various aspects of drug safety, including regulatory compliance, risk management, and best practices.
6. Non-governmental organizations (NGOs) and non-profit organizations: Some NGOs and non-profit organizations, particularly those focused on public health and patient safety, may employ pharmacovigilance professionals to monitor and evaluate the safety of medications used in public health programs.
7. Health technology assessment (HTA) agencies: HTA agencies evaluate the clinical and economic value of medicinal products and may employ pharmacovigilance experts to assess the safety aspects of new therapies.
These are just a few examples of the many organizations where pharmacovigilance professionals can find job opportunities. The specific roles and responsibilities will vary depending on the organization, its size, and the scope of its pharmacovigilance activities.
Pharmacovigilance Jobs Salaries In Different Countries
Pharmacovigilance job salaries can vary significantly depending on factors such as the role, the candidate's experience and qualifications, the organization, and the location. Here, we provide an overview of average pharmacovigilance salaries in different countries. Please note that these figures are approximate and may change over time due to various factors like inflation, exchange rates, and regional differences in the cost of living. For more accurate and up-to-date salary information, please refer to local job listings or salary survey websites.
1. United States:
- Entry-level Pharmacovigilance Associate: $50,000 - $70,000 per year
- Pharmacovigilance Scientist: $70,000 - $100,000 per year
- Senior Pharmacovigilance Scientist/Manager: $100,000 - $140,000 per year
- Pharmacovigilance Director: $140,000 - $200,000 per year
2. United Kingdom:
- Entry-level Pharmacovigilance Associate: £25,000 - £35,000 per year
- Pharmacovigilance Scientist: £35,000 - £50,000 per year
- Senior Pharmacovigilance Scientist/Manager: £50,000 - £70,000 per year
- Pharmacovigilance Director: £70,000 - £100,000 per year
- Entry-level Pharmacovigilance Associate: CAD 40,000 - CAD 60,000 per year
- Pharmacovigilance Scientist: CAD 60,000 - CAD 85,000 per year
- Senior Pharmacovigilance Scientist/Manager: CAD 85,000 - CAD 120,000 per year
- Pharmacovigilance Director: CAD 120,000 - CAD 160,000 per year
- Entry-level Pharmacovigilance Associate: INR 2 - 4 lakhs per year
- Pharmacovigilance Scientist: INR 4 - 8 lakhs per year
- Senior Pharmacovigilance Scientist/Manager: INR 8 - 15 lakhs per year
- Pharmacovigilance Director: INR 15 - 25 lakhs per year
- Entry-level Pharmacovigilance Associate: €40,000 - €50,000 per year
- Pharmacovigilance Scientist: €50,000 - €70,000 per year
- Senior Pharmacovigilance Scientist/Manager: €70,000 - €90,000 per year
- Pharmacovigilance Director: €90,000 - €130,000 per year
- Entry-level Pharmacovigilance Associate: AUD 50,000 - AUD 70,000 per year
- Pharmacovigilance Scientist: AUD 70,000 - AUD 100,000 per year
- Senior Pharmacovigilance Scientist/Manager: AUD 100,000 - AUD 140,000 per year
- Pharmacovigilance Director: AUD 140,000 - AUD 180,000 per year These salary ranges are for general reference only. Actual salaries may vary based on various factors, such as experience, qualifications, job title, and the specific organization or region.
CROs That Offer Pharmacovigilance Jobs
Contract Research Organizations (CROs) provide a variety of services to the pharmaceutical and biotechnology industries, including pharmacovigilance. Some of the well-known CROs that offer pharmacovigilance job opportunities include:
1. IQVIA (formerly QuintilesIMS): A leading global CRO providing a wide range of clinical research and pharmacovigilance services to clients in the healthcare sector.
2. PAREXEL International: A multinational CRO that offers comprehensive drug development and pharmacovigilance solutions for the pharmaceutical and biotechnology industries.
3. ICON plc: A global provider of outsourced development and commercialization services to the pharmaceutical, biotechnology, and medical device industries, including pharmacovigilance and safety services.
4. PRA Health Sciences: A CRO offering a broad range of services, including clinical research, data management, and pharmacovigilance, to clients in the healthcare sector.
5. Covance (part of LabCorp): A global CRO that provides drug development and pharmacovigilance services to pharmaceutical and biotechnology companies.
6. Syneos Health (formerly INC Research/inVentiv Health): A global CRO offering integrated clinical and commercial solutions, including pharmacovigilance and safety services, to clients in the healthcare industry.
7. Pharmaceutical Product Development (PPD): A global CRO providing comprehensive drug development and pharmacovigilance services to the pharmaceutical and biotechnology industries.
8. Charles River Laboratories: A CRO that offers a wide range of preclinical and clinical laboratory services, including pharmacovigilance, to support the development of new therapies.
9. Medpace: A global CRO that specializes in providing clinical research, regulatory, and pharmacovigilance services to clients in the biopharmaceutical industry.
10. WuXi AppTec: A multinational CRO that provides a broad range of services, including drug development, clinical research, and pharmacovigilance, to pharmaceutical and biotechnology companies. These are just a few examples of the many CROs that offer pharmacovigilance job opportunities. Job seekers interested in pharmacovigilance roles can explore the career pages of these companies, as well as other CROs, to find suitable job openings.
SAS Or Pharmacovigilance Which One Is Better For Career
Choosing between a career in SAS (Statistical Analysis System) and pharmacovigilance depends on your interests, skills, and long-term career goals. Both fields have their own merits and can offer rewarding career paths. Here is a brief comparison of the two fields to help you make an informed decision:
- SAS is a powerful software suite used for data management, statistical analysis, and data visualization. It is widely used in various industries, including pharmaceuticals, finance, healthcare, and market research.
- SAS professionals, such as data analysts, statisticians, and programmers, are responsible for processing, analyzing, and interpreting data to support decision-making in their organizations.
- A career in SAS requires strong analytical and programming skills, as well as a good understanding of statistics and data management principles.
- Demand for SAS professionals is high across various industries, providing a wide range of job opportunities and career growth prospects.
- Pharmacovigilance is the science and practice of monitoring, detecting, assessing, and preventing adverse effects or other drug-related problems associated with the use of pharmaceutical products.
- Professionals in pharmacovigilance, such as drug safety associates, pharmacovigilance scientists, and risk management specialists, work to ensure patient safety and promote public health.
- A career in pharmacovigilance requires a background in life sciences, pharmacy, medicine, or a related field, along with strong analytical and communication skills.
- Pharmacovigilance jobs are primarily concentrated in the pharmaceutical, biotechnology, and clinical research industries, offering a more focused career path with opportunities for specialization and growth within the drug safety domain.
Ultimately, the choice between a career in SAS or pharmacovigilance depends on your personal interests and preferences. If you enjoy working with data, programming, and statistics, and are interested in exploring opportunities across different industries, a career in SAS may be more suitable for you. On the other hand, if you have a strong background in life sciences and are passionate about patient safety and public health, a career in pharmacovigilance may be a better fit. Consider your strengths, interests, and long-term career goals to make the best decision for yourself.
1. Comprehensive Curriculum: Our online pharmacovigilance course covers all aspects of drug safety, including adverse event reporting, signal detection, risk management, and regulatory compliance. Learn about global pharmacovigilance regulations and guidelines, such as those from the FDA, EMA, and ICH.
2. Expert Instructors: Gain insights and guidance from experienced pharmacovigilance professionals who bring real-world knowledge and practical examples to the classroom, ensuring you receive the most relevant and up-to-date information.
3. Interactive Learning: Our dynamic and engaging course content combines video lectures, case studies, quizzes, and assignments to promote active learning and enhance your understanding of key concepts.
4. Hands-on Experience: Develop practical skills through simulated projects and exercises designed to mimic real-world pharmacovigilance scenarios, preparing you to excel in your future workplace.
5. Flexible Learning: Our online course allows you to learn at your own pace and on your own schedule, providing the perfect balance between your professional and personal commitments.
6. Dedicated Placement Support: We are committed to your success! Our placement team works closely with you to help you build an impressive resume, prepare for interviews, and connect with potential employers in the pharmaceutical, biotechnology, and clinical research industries.
7. Networking Opportunities: Interact with fellow course participants and expand your professional network, opening doors to new opportunities and collaborations within the pharmacovigilance community.
8. Access to Course Materials: Gain lifetime access to our course materials, ensuring you can revisit important concepts and stay up-to-date with the latest developments in the field.
9. Certification: Upon successful completion of the course, you will receive a recognized certificate that demonstrates your knowledge and expertise in pharmacovigilance, enhancing your credibility in the job market.
Don't miss this opportunity to build a successful career in pharmacovigilance with our comprehensive online training program and placement support. Enroll today and take the first step towards a bright future in the dynamic world of drug safety!
Students Testimonials on pharmacovigilance Course
Pharmacovigilance also known as drug safety ensures rigorous testing of medicine to improve patients care and reduce the risk of negative side effects. Pharmacovigilance monitors the drug through out their life cycle and certifies whether a drug works and it is safe to use. The role of PV is to assess benefit and risk ratio, whether benefits outweigh the risk.
Pharmacovigilance process is crucial during clinical trials to ensure it is safe for patient use, but it is also important to continuously monitor the drug once it is marketed. The medicines are not safe after clinical trails because;
- The number of people who receive the drug in a trial are small in comparison to general distribution. More common side effects only can be identified in clinical trials and rare events may emerge only after millions of people receive the drug.
- High risk population (such as pregnancy, elderly, paediatric etc.) are not involved in clinical trials, but they may receive the medicine for general use once it is marketed.
- The trials are conducted for shorter duration (few months or couple of years), there might be few events which can be observed only when the drug is in market for many years.
- World Health Organisation (WHO)
- The International Council for Harmonisation (ICH)
- the Council for International Organizations of Medical Sciences (CIOMS)
- Then, there are country-level regulatory agencies such as US-FDA, UK-MHRA, Japan-PMDA, Health Canada, Australia - TGA, China-FDA, European Medicines Agency, the Central Drugs Standard Control Organization India, etc,.
A Pharmacovigilance system is that facilitates collection, storage and ongoing assessment of safety information associated with medical product; allows periodic analysis of benefit-risk ratio; enables effective communication of risk information to consumers to prevent/minimize the risk; evaluates effectiveness in risk mitigation steps; identifies gaps in the knowledge on drug/vaccine safety profile and defines easier to address the gaps.
Medicines, herbal products, biologics, medical devices, blood products, vaccines, cosmetics, traditional and dietary supplement products, veterinary and tobacco products.
- Open/unblinded: A clinical study in which both investigators and patients are aware of what treatment has been assigned,
- Single blinded: A clinical study in which, the patient unaware of which treatment they are taking, while the investigators are aware of whether the treatment is new, standard, or placebo.
- Double blinded: A clinical study in which neither the patient nor the investigator knows the identity of the assigned intervention
- Triple blinded: A clinical study in which the investigators and participants, all members of the sponsor’s project team (e.g., the project clinician, statistician, and data manager), and even the DSMC are blinded.
It is a unique type of clinical trial in which the clinician is both the sponsor and the investigator. Investigator initiated studies (IIS) are clinical studies initiated and managed by a non-pharmaceutical company researchers, like individual investigators, institutions, collaborative study groups or cooperative groups. The researcher is responsible for the legal and regulatory responsibilities of the trial sponsor for the conduct and management of the study as defined by all applicable laws and regulations.
A descriptive term for a clinical study in which patients are randomly assigned to one of two or more treatment arms of the study. clinical trial is a randomized controlled trial only when participants are randomly allocated to the group receiving the treatment and a control group.
- Definition: MedDRA is a clinically-validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry. The terminology is used through the entire regulatory process, from pre-marketing to post-marketing, and for data entry, retrieval, evaluation, and presentation.
- MedDRA Hierarchy:
- System organ classes (SOCs)
- Higher level group terms (HLGTs)
- Higher level terms (HLTs)
- Preferred terms (PTs)
- Lowest level terms (LLTs)
Reference safety information documents (RSI)
Causality assessment is the assessment of relationship between a treatment drug and the occurrence of an adverse event. It is also used to evaluate and to check that the particular treatment is the cause of an observed adverse event or not and also to understand how close is the relationship between treatment drug and event
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- Introduction to PV Unlimited
- Brief history of PV Unlimited
- Importance of adverse event reporting Unlimited
- Reasons for ADR collection Unlimited
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- FDA Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment Unlimited
- FDA regulation for IND safety reporting and post market safety reporting Unlimited
- PBRER Unlimited
- PADER Unlimited
- DSUR reports Unlimited