3 months online certification course in pharmacovigilance

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Here are details of our ‘3 months online certification course in Pharmacovigilance’

Course schedule

Duration- 3 months
Time and days- Every weekends
Syllabus covered
1) Overview Clinical research and History and development of PV
2) Basics of Bioequivalence, Bioavailability, Pharmacodynamics and pharmacokinetics.
3) Adverse Drug Reactions, Key Terminologies in PV, Methodologies in Pharmacovigilance
4) Clinical trials-Types, Phases
5) ICSR management and case studies
6) MedDRA coding
7) Seriousness and causality assessment
8) Narrative writing
9) Safety database overview- example- Argus, Aware, Aris g etc.
10) Special scenario in PV
11) Signal detection and management
12) Overview of Periodic Safety Update Reports (PSURs), Aggregate reporting, medical writing, Importance of local literature search
13) MICC (Medical information contact center) overview
14) Pharmacovigilance System Master File (PSMF), Risk Management Planning (RMP), Reference Safety Information (RSI)
15) PV inspection and Audits
16) Contract research organization (CRO)
17) Pharmacovigilance Regulations in Various Countries

Along with this we provide skill development classes which covers
1)resume preparation
2)HR question
3) individual mock interview
4)Job searching skill
5)presentation skill (PPT presentation)
6)HR communication skill
7)effective email writing skill

Benefits of course
1) Certification from ISO certified organization
2) Expert guide having more than 10+ year of experience in core pharmacovigilance domain
3) Live lectures with recording
4) 100% placement assistance
5) study material provided

Course fees for LIVE classes
For indian students
Basic fees-9999/-

Offer price-8999/- (for early admission)
How to enroll

Pay online to 9423272876 via gpay or phonepay or Paytm
After payment kindly share your email ID, name, qualification and location on whatsup to 9423272876
You will get email confirmation and also added in class whatsup group
You will receive a book to refer before class

View All Courses

Syllabus covered
1) Overview Clinical research and History and development of PV
2) Basics of Bioequivalence, Bioavailability, Pharmacodynamics and pharmacokinetics.
3) Adverse Drug Reactions, Key Terminologies in PV, Methodologies in Pharmacovigilance
4) Clinical trials-Types, Phases
5) ICSR management and case studies
6) MedDRA coding
7) Seriousness and causality assessment
8) Narrative writing
9) Safety database overview- example- Argus, Aware, Aris g etc.
10) Special scenario in PV
11) Signal detection and management
12) Overview of Periodic Safety Update Reports (PSURs), Aggregate reporting, medical writing, Importance of local literature search
13) MICC (Medical information contact center) overview
14) Pharmacovigilance System Master File (PSMF), Risk Management Planning (RMP), Reference Safety Information (RSI)
15) PV inspection and Audits
16) Contract research organization (CRO)
17) Pharmacovigilance Regulations in Various Countries
Along with this we provide skill development classes which covers
1)resume preparation
2)HR question
3) individual mock interview
4)Job searching skill
5)presentation skill (PPT presentation)
6)HR communication skill
7)effective email writing skill

Course Curriculum

Class 1
This Class Covers Following topics 1) Introduction to Pharmacovigilance and career guidance 2) Overview of drug Discovery and clinical trial phases 3)Overview of pharmacovigilance

Introduction to Pharmacovigilance

02:06:35

Class 2
This class covers following topics 1) Importance of drug development 2) PK and PD Analyses 3) PK studies and clinical research 4) What is pharmacodynamics 5) What is bioavailability and cause of bioavailability 6)Bioequivalence

Class 3
This topics cover following points 1) Adverse Drug Reactions (ADR) Vs Adverse Drug Event (ADE) 2) Grading of severity of adverse drug reaction 3) Classification of ADR 4) Types of allergic reactions 5) Teratogenicity 6) Key Terminologies in PV

Class 4
This topics covers following points 1)History of development of human research protection 2) Good clinical practices 3)What is clinical trial and what is types of clinical trial 4)Clinical trial design 5)Clinical trial phases

Class 5
This topics covers following topic- 1)ICH GCP E6 Guidelines 2) Clinical trial monitoring 3) Types of Clinical trial monitoring 4)Sources of ICSR

Class 6
This topic covers following point 1) What is MedDRA coding 2)MedDRA Point to consider 3)General Term selection principle

Class 7
This session covers following point 1) Future opportunities in PV 2) How to find jobs in pv, 3) Career growth in PV

Class 8
This topic covers following point 1) What is MICC 2) What is the difference between MICC and BPO 3) How consumer contact MICC 4) Roles and responsibilities of MICC executive 5) What is AE 6) What is PQC 7) Skill required for MICC

Class 9
This topic covers following point 1) Introduction 2) Coding of adverse event 3) Objective of causality assessment and how its performed 4) Methods

Class 10
This topic covers following point 1) PV System Components 2)Oversight and Management of Service Providers 3)Quality Management Systems 4)PV System Master File (PSMF) 5)Commercial Activities 6)Risk Management Plan (RMP)

Class 11
https://youtu.be/tMON8Zv7J8w

Class 12
This Class covers Resume Preparation

Class 13
This class covers Individual students resume monitoring

Class 14
This Class Covers HR questions for freshers

Class 15
This class Covers HR Questions for Experienced student

Class 16
This class covers Job searching skills Key skill for searching jobs Resume ,cover letter,email writing Online platform to find job opportunity at entry level Tips for freshers while searching for jobs Common mistakes freshers makes while job hunting LinkedIn profile

Class 17
This Class covers following point Walk in interview Scheduled interview Difference between walking vs scheduled interview Virtual interview Telephonic interview Walk in interview tips

Class 18
This class covers ppt presentation of students on various topic

Class 19
This class covers ppt presentation of students on various topic

Class 20
This class covers 1) Argus database 2) Aggregate report in PV

Class 21
This class covers PPT presentation of students on various topic

Class 22
This class covers individual mock interviews of students

Class 23
This class covers revision on various topics

Class 24
This class covers mock interviews of individual students

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