Certification Course in Pharmacovigilance (Live)
Live weekend batches Internship 100% placement assistance
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About this course
Live weekend batches Internship 100% placement assistance
Live enrolment. After payment our team will contact you for live sessions.
Syllabus
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
1) Expert guide having more than 10+ year of experience in core pharmacovigilance domain
2) Live lectures with recording
3) 100% placement assistance
4) Study material provided
5)Dual Certification from ISO certified (AI + Pharmacovigilance)
6) Internship Opportunity Included
Why choose this course
Syllabus
Clinical research & PV history
ADR, ICSR and MedDRA coding
Causality, narratives and safety databases
Signal detection, PSUR and audits
Internship and placement support