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Pharmacovigilance Training
Pharmacovigilance course provided Ramya at Great Online training. Pharmacovigilance Training included real time project and ARGUS safety data base. Pharmacovigilance course tutorial for all students who are looking career in this area.Live Online Training
march,2023
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Hello Guys, We would be glad to conduct demo class for you Please Join. Pharmacovigilance Online Demo Session @ 7:00 AM Indian Time (IST). If you have any
Event Details
Hello Guys,
We would be glad to conduct demo class for you Please Join.
Pharmacovigilance Online Demo Session @ 7:00 AM Indian Time (IST).
If you have any query’s (like course details, fee details, about timings) you can discuss everything in your demo session or you can call +919966956770
The main purpose of demo is to explain the common doubts what you have and the scope of Job opportunities in SAS.
We will send meeting details to your registered email address and if you face any challenges in attending the meeting feel free to call us at +919966956770 .
Live Online/Video Based classes can be conducted by the trainers with the students who can be from any part of this world. Students can join the live class from their respective places.
Please find the brief details of the course below and more details HERE
Course Name | Pharmacovigilance |
Duration | 45 days / 1 Hr per day |
Training Days | Monday to Friday(EST) |
Course Materials | Assignments, Books, Server access for practice |
Register for Free Demo
Time
march 31(friday) 7:00am - march 31(friday) 8:00am IST View in my time
Organizer
Event Details
Hello Guys, We would be glad to conduct demo class for you Please Join. Pharmacovigilance Online Demo Session @ 7:00 PM Indian Time (IST). If you have any
Event Details
Hello Guys,
We would be glad to conduct demo class for you Please Join.
Pharmacovigilance Online Demo Session @ 7:00 PM Indian Time (IST).
If you have any query’s (like course details, fee details, about timings) you can discuss everything in your demo session or you can call +919966956770
The main purpose of demo is to explain the common doubts what you have and the scope of Job opportunities in SAS.
We will send meeting details to your registered email address and if you face any challenges in attending the meeting feel free to call us at +919966956770 .
Live Online/Video Based classes can be conducted by the trainers with the students who can be from any part of this world. Students can join the live class from their respective places.
Please find the brief details of the course below and more details HERE
Course Name | Pharmacovigilance |
Duration | 45 days / 1 Hr per day |
Training Days | Monday to Friday(EST) |
Course Materials | Assignments, Books, Server access for practice |
Register for Free Demo
Time
march 31(friday) 7:00pm - march 31(friday) 8:00pm IST View in my time
Organizer
Register today for a free demo
Brief details of this course training
Name of the Course | Pharmacovigilance Advanced Course |
Duration | 45 days / 1 hr per day |
Training Days | Monday to Friday(EST) |
Course Materials | Videos, Books |
Enroll for Pharmacovigilance Self-paced Course
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. 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.Definition:
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.Pharmacovigilance Interview Questions by Ramya










Aims of Pharmacovigilance:
- To improve patient care about drugs and keep the patient safe from adverse effects of medicines, and all medicinal and paramedical interventions.
- To contribute to the assessment of benefit, risk and effectiveness of medicines.
- To promote understanding, education and training about this field and its effective communication to health professionals and public.
- To encourage safe and rationale use of medicines.
Objective of Pharmacovigilance:
- To detect the new adverse effects, drug interactions and contraindications.
- Communication of information about adverse events so that they occur less frequently.
- Reevaluation of risks and benefit ratio for effective use of medicines in patients to reduce side effects and more benefits.
- Identification of mechanisms that cause adverse effects of drugs.
Pharmacovigilance process - Adverse event process flow
The pharmacovigilance process includes multiple phases of handling adverse event report. Phase 1: Collection of all adverse event reports including serious, non serious, new or already known event. Adverse event reports are collected through different sources which are;- Spontaneous or voluntary reports
- Clinical trials and Post marketing study Reports
- Literature reports
- License partner reports
- Regulatory authority reports
- Legal reports
- Case validity assessment
- Database entry
- Event selection and coding with MedDRA
- Product coding
- Seriousness assessment
- Causality assessment
- Labelling assessment
- Writing narratives
- Medical input
- Periodic report compilation/aggregate reporting
- Signal management
- Risk-benefit assessment

Students Testimonials on pharmacovigilance Course







Basic fundamentals of ICSR
Individual Case Study Report (ICSR) is an adverse event report for an individual patient and is source of data in pharmacovigilance.
Sources of AE reporting:
- Spontaneous or voluntary reports - As per ICH E2D, A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.
- Clinical trials and Post marketing study Reports - The Adverse events reported while patient participating in clinical trials or post marketing trials.
- Literature reports - Literature report is any adverse drug reactions reported in
- Published abstracts or
- Articles in medical/scientific journals
- Unpublished manuscripts involving case reports
- Important safety findings or clinical studies including posters, letters to the editors, and associated communication from scientific meetings.
- License partner reports - A Pharma company get into a licensing agreement with third party to produce or market a drug formulation that the other company has developed. Each license partners does have pharmacovigilance agreement to meet safety requirements in marketing country. The cases received from other pharmaceutical company which has PVA agreement are handled as license partner cases.
- Regulatory authority reports - If a consumer or healthcare professional directly report adverse events to regulatory authority (i.e, FDA, EMA etc..) not to marketing holder (pharmaceutical company), then those reports will be shared to marketing holders by regulatory authorities. This type of cases which were received by companies from regulatory authority are handled as regulatory authority cases.
- Legal reports - If the reporter file a lawsuit against medicine manufacturer and the report received from the lawyer are handled as legal case.
- Identifiable patient
- Identifiable reporter
- A suspect drug
- An adverse event or adverse drug reaction
Types of ICSR reports:
Based on source of adverse events the ICSRs are categorized into solicited and non-solicited reports.- Solicited Reports are the ICSRs which were originated from a organized data collection system such as;
-
- Interventional and non interventional clinical trials
- Patient registries
- Post marketing studies
- Patient support programs
- Marketing programs
- Investigator initiated trials
- Compassionate use programs
- Non solicited reports are the ICSRs which originated from unorganized data collection system such as;
-
- Literature cases
- Legal reports
- Regulatory authority reports
- Spontaneous reports
- Social medial reports
Steps involved in ICSR:
Once the report received from one of the sources mentioned above, the case undergoes multiple processing steps before submitting to regulatory authorities. The steps involved in ICSR case processing are:- Case validity assessment
- Database entry
- Event selection and coding with MedDRA
- Product coding
- Seriousness assessment
- Causality assessment
- Labelling assessment
- Writing narratives
- Medical input
Regulatory submission timelines:
Globally ICSR are reported under 3 categories :- Clinical Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the NCA (national competent authorities)/HA (health authorities).
- Clinical trial other Serious cases and safety issues are reported in 15 days calendar days timeframe.
- Serious post marketing cases are reported within 15 calendar days to the NCA (national competent authorities)/HA (health authorities)
- Non-Serious cases are reported within 90 calendar days to the EU health authority (EMA). Not mandatory for non-EU countries.
Basics of Aggregate reporting
Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide.Types of aggregate reports:
- Pre-marketing report:
- IND annual reports
- Clinical study reports (CSR)
- Development Safety Update Report (DSUR) (annual reports)
- Post-marketing report:
- Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR)
- Periodic Adverse Drug Experience Report (PADER).
- NDA and ANDA annual reports
Signal Management
The definition of a signal as provided by the Council for International Organizations of Medical Sciences (CIOMS) 8 Working Group: Information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action. Signal Management: A set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking. Activities include:- Signal detection
- Signal validation
- Signal prioritization
- Signal assessment
- Recommendation for action
- Exchange of information
What type of jobs are there in Pharmacovigilance and which one I should consider?
There are multiple areas in pharmacovigilance, some need specialization and some need medical/clinical/pharmacology knowledge. Core pharmacovigilance team require medical/clinical/pharmacology knowledge. This team handles ICSR reports, aggregate reporting, signal management, preparing RMPs/REMS/SMPs. These jobs require qualification of healthcare professional (physicians, nurses, pharmacists, dentists, veterinarians, Ayurvedic physicians). At an entry level one can apply for drug safety associate role who handles ICSR reports. There are multiple roles in ICSR such as case intake/triage team, case processing, quality review and medical review. Medical review team requires physicians but other teams need healthcare professionals. To apply for this role one must have knowledge in pharmacovigilance processes and guidelines, must have skill set to read incoming hospital records, patient records, medical literature, case report forms, labelling documents etc. Major activities that are reading medical records or patient adverse event reports, writing narratives, event coding with MedDRA, product coding with WHODD, event seriousness assessment, labelling and causality assessment, entering data into drug safety database like ARGUS, ArisG etc., Starting level job titles are:- Pharmacovigilance specialist
- Pharmacovigilance scientist
- Drug safety associate
- Safety and pharmacovigilance associate
- Signal detection drug safety associate
Job offering Organizations on the Globe
Each and every pharmaceutical company has their own pharmacovigilance team as it mandatory as per regulatory requirements/WHO/ICH. In large pharmaceutical companies, more than 100000 adverse event reports can be received each year. To handle the cases effectively and to meet the regulatory timelines and compliance, companies started outsourcing the PV unit. Trained Pharmacovigilance associate can apply for employment opportunities in the following organizations:- Pharma and biotech companies
- Contract research organizations (CROs)
- Knowledge process organizations (KPOs)
- Regulatory authorities
-
Accenture
-
Cognizant
-
TCS
-
IQVIA
-
Parexel
-
Kinapse
-
APCER life sciences
-
PPD
-
Bioclinica
-
Tech Mahindra
-
Pharmalex
-
Primivigilance
Pharmacovigilance FAQs
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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Course Curriculum
-
- Introduction to PV Unlimited
- Brief history of PV Unlimited
- Importance of adverse event reporting Unlimited
- Reasons for ADR collection Unlimited
-
- GVP Modules training Unlimited
- Eudravigilance requirements Unlimited
- 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
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When I first searched about Pharmacovigilance training classes online, I found Great Online Training videos. The moment I listened to them I knew that was it!!!!! I joined the course immediately and I am completely satisfied with the training. The trainer is very knowledgeable and patient and very good about explaining the concepts thoroughly. She tries to answer all the questions you might have to the maximum extent possible. I am very confident about PV now after taking her classes despite of having science background. I would recommend to any one wanting to learn Pharmacovigilance. The trainer is very passionate about the teaching, she tries to update the materials and finds new ways to teach students.
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