Pharmacovigilance Training in Oracle Argus Safety Database

Pharmacovigilance Training
Copyright © 2021 Gratisol Labs 1
5/12/2021

About Gratisol Labs
• Gratisol Labs is a leading training institute in pharmaceutical
sciences offering customized training programs in Pharmaceuticals,
Biotechnology, Clinical Research, Clinical Data Management,
Pharmacovigilance, Medical Writing, Medical Coding, Clinical SAS &
Regulatory Affairs with proclaimed objective of becoming a centre
of excellence for advanced studies in pharmaceutical sciences.
• Gratisol Labs has achieved amazing and consistent growth,
quantitatively and qualitatively to emerge as a Contract Research
Organization in a short span of time.
• Gratisol Labs offers training services in Clinical Research Training,
Clinical Data Management Training, Pharmacovigilance Training,
Medical Writing Training, Regulatory Affairs Training, Bioinformatics
Training, Clinical SAS Training, CDISC SDTM Training, Pharmaceutical
Equipment Validation Training.
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Copyright © 2021 Gratisol Labs

Reporting of Adverse Events
PHARMACOVIGILANCE
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Pharmacovigilance Certification
Training Overview
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The World Health Organization (WHO) defines
Pharmcovigilance as “science and activities relating to the
detection, assessment, understanding and prevention of
adverse effects or any other possible drug-related problems”.
To simply put, Pharmcovigilance is a system to monitor the
safety and effectiveness of medicines and other
pharmaceutical products.
Pharmacovigilance Training is essential for Pharmaceutical
and healthcare organizations to ensure your operations
comply with latest regulatory guidelines. At Gratisol Labs we
provide hands on practical training on Pharmacovigilance
process.

• Adverse drug reaction (ADR) - A response to a drug which is
noxious and unintended and which occurs at doses normally used in
man.
• Adverse Event (AE) - A negative experience encountered by an
individual during the course of a clinical trial, which may or may not
be associated with a drug.
• Adverse Event Reporting System (AERS)
• Council for International Organizations of Medical Sciences
(CIOMS)
• Medical Dictionary for Regulatory Activities (MedDRA)
• Periodic Safety Update Report (PSUR)
• Serious Adverse Events (SAE) - Any adverse event (AE) that is
fatal, life-threatening, permanently disabling, or which results in
hospitalization, initial or prolonged.
Key Definitions/Acronyms
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Objectives of Pharmacovigilance
Long term monitoring of drug safety in order to :
• Identify Previously unknown hazards
• Evaluate changes in benefits and risks
• To provide optimal information to users
• Take action to promote safer use
• Monitor impact of action taken
• To promote understanding, education and clinical training in
pharmacovigilance and its effective communication to health
professionals and the public.
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Historical Background
Thalidomide Tragedy
Thalidomide was heavily promoted in 1960 and was marketed in about
46 countries.
• The drug claimed to prevent nausea during pregnancy.
• Result was - Deformed infants were born with phoecomelia
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Birth of Pharmacovigilance
• In 1962 USA passed an amendment that Federal Food , drug and
cosmetic act- required both safety & efficacy data.
• WHO set up its International Drug Monitoring Program after the
thalidomide disaster.
Since 1978 the Program has been carried out by the Uppsala
Monitoring Centre (UMC) in Sweden. Responsible for the collection of
data about adverse drug reactions from around the world, especially
from countries that are members of the WHO, and the generation of
signals of drugs which might possibly have problematic side-effects.
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Need for Pharmacovigilance?
When a drug is approved and placed on the market, it does not
necessarily mean it is safe!
The main reason to monitor ADR for an approved product is due to
limitation of pre-marketing clinical studies to identify safety issues.
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Contd.
Some of the reasons why pre-marketing studies are inadequate to
cover all aspects of drug safety:-
• Relatively small number of patients.
• Frequent exclusion of individuals who may be at greater risk of
ADRs.
• The structured nature of clinical studies.
• Duration of clinical studies is limited and there could be long latent
period between starting the drug and the development of ADR which
may not be detected in clinical studies.
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Contd.
Post Marketing Surveillance
Pharmacovigilance originated in the post-marketing arena, when
additional data on safety & efficacy could not be collected through
phase 1-3.
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Overview of Pharmacovigilance
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Pharmacovigilance Process
1. Reporting of an adverse drug reaction
– Spontaneous Reporting
unsolicited communication by Healthcare professional or Consumer to a
company, regulatory authority or other organization. Ex CIOMS I Form
– Mandatory Reporting
Manufacturers/Sponsors are required to submit reports for the newly marketed
drug to the competent authorities, in the form of a PSUR.
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Contd.
2. Data Collection and Storage
Reported ADR data is entered and stored in a database. Database
is assumed to be a static system, in which nothing can change.
3. Data Collation
Once the ADR data is obtained the data is sent to the WHO
Uppsala Monitoring Center where the data is stored in the central
database.
4. Analysis
ADR data in the central database is analyzed and based on that a
signal can be generated. Signal detection is one of the most
important objectives of pharmacovigilance. The whole process of
risk/benefit evaluation depends on effective detection of signals.
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Contd.
5. Communicate Product Risk
If the signal is positive , it is communicated to
safety review board, benefit & risk assessment
is done. Evaluated risk is then communicated.
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Key Regulations governing Pharmacovigilance
• FDA – Food and Drug Administration
• EMEA – European Medicine Agency
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Adverse Event Reporting Applications
Fast and Reliable reporting of ADR (adverse drug reaction) data is
important task for pharmaceutical companies.
Drug Safety applications:-
AERS, Arisg , ARGUS, S3, CARES
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Oracle Argus Safety Database
in Pharmacovigilance
• Oracle Argus Safety ensures Global Regulatory Compliance. It
provides a fully integrated platform of end-to-end Pharmacovigilance
solutions designed to ensure regulatory compliance and
comprehensive product stewardship.
• Argus Safety is the industry’s leading Drug Safety System to
manage the entire Case Lifecycle. It provides the most
comprehensive global Adverse Events case data management and
regulatory reporting in the pharmaceutical industry.
What are the Benefits:-
• It ensures global regulatory compliance
• It make process faster, science-based safety decisions.
• It integrates safety and risk management.
• It lowers the cost of Pharmacovigilance.
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Pharmacovigilance programme of India
(PVPI) was launched in July 2010
To ensure that the benefits of use of medicine
outweighs the risks and thus safeguard the health
of the Indian population
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Why should students opt
for Pharmacovigilance Career
• It is primarily due to the work of Pharmacovigilance
professionals that the drugs in the market that we
consume are mostly safe and those that are found
harmful are taken off the market.
• Pharmacovigilance professionals continuously
monitor the safety of the drugs in clinical trials as
well as the drugs already being sold in the market.
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Career Growth in PV
Industry
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Job prospects
• The Entry level job for Pharma students is DSA (Drug Safety
Associate).
• With experience of 2-3 years one will become DSS (Drug Safety
Scientist).
• With an overall of 7-10 years experience in this position individuals
can easily become a Team lead or Team manager based on the
company.
• Lastly, individuals end up acquiring the position of a Director or Vice-
President with an experience of 9-10 years.
Pay-scale (Per Month):
• Fresher: Rs 15,000-30,000
• After 5 years: Rs 50,000-60,000
• After 10 years: More than Rs 80,000-90,000
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Growth prospect:
Individuals trained in Pharmacovigilance will find
good job options in the following sectors:
• Pharmaceutical Companies (MNCs & Indian) &
Biotech companies.
• Clinical Research Organizations.
• KPOs like Accenture & Quintiles.
• Regulatory Agencies like DCG (I) & CDSCO.
• Pharmacovigilance units in Medical colleges &
Hospitals.
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Deliverables from Gratisol Labs
• Course Material
• Training Certificate
• Mock Interview
Questions
• Soft Skills Training
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Gratisol Labs Placement Model
Mock Interview 1st Round
Satisfactory Poor
•Soft Skill
development
•CR Input
•Communication
Mock Interview 2nd Round
Good Satisfactory
Mock Interview 3
Excellent
Placement
•Soft Skill
development
•CR Input
•Communication
Interview
Interview
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Success Stories...
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PLACEMENTS (1)
NAME COMPANY CITY
Sana Rafiuddin PAREXEL HYDERABAD
Saba zia NOVARTIS Hyderabad
Debarun Roy CLINNOVATION Kolkata
Dr Preeti Bhatia NOVARTIS Hyderabad
Bhusana Das Deka QED USA
Prem Kumar ICON plc Chennai
Santosini NIMS Hyderabad
A. Renu Suven Life Sciences Hyderabad
Keerthi PAREXEL Intl Hyderabad
Vivek Pathak Makrocare Hyderabad
5/12/2021 31

PLACEMENTS (2)
Sarita Upadhyay Yashoda Hospital Hyderabad
Sohini Sanyal Makrocare Hyderabad
Rosalin Dalai Makrocare Hyderabad
Vamsi Krishna Accenture Bangalore
Kalyan Accenture Chennai
Subhoshree Ghosh CLINNOVATION Kolkata
Anurag Shukla Care Worldwide Hyderabad
G.V. Reddy Accenture Hyderabad
Luke Arete Clinical Research Hyderabad
Veronica Nova Nord. Bangalore
Pradipta bhaumic Excell Life Sciences Kolkata
Vineeta Biocon Bangalore
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PLACEMENTS (4)
Suma parijatha Mahindra Satyam Hyderabad
Md.Zoheb St Jude CR Services Hyderabad
Suneeta vandanapu Yashoda Hyderabad
Punyasloka Pattnaik Manipal Accunova Orissa
Surabhi Sharma Kolkata
Naina Bhanushali Makrocare Hyderabad
Aseema Ghouse NIMS Hyderabad
Vineet Amvin Hyderabad
Kiran Vyas AIG Hyderabad
Ajay Kumar TCS Mumbai
Kranthi Boyini Quintiles Bangalore
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Contact Us
Gratisol Labs – Hyderabad
Vasavi’s MPM Grand, 8th Floor, Unit Number 5,
Yella Reddy Guda Road, Beside Ameerpet Metro Station
Ameerpet, Hyderabad-500073.
Cell: +91 9705790302, 8885198390,
E-mail – training@gratisol.com
Web: www.gratisol.com, www.gratisollabs.com
General Inquiries:training@gratisol.com

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Pharmacovigilance Training in Oracle Argus Safety Database

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