Online course in Pharmacovigilance
₹8,999.00
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)zresume 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
Product Description
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)zresume 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
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