Certification
in Pharmacovigilance
100% Placement Assistance | Industry Accredited Program | Specialization |
Job Oriented
Global industry size is over US$40 billion, and in India
industry is expected to touch the turnover of US$2 billion in the next two
years. Other key global markets like China, South East Asia, Europe and
Americas continue to grow in double digit.
Regulatory bodies such as the USFDA and EMEA are intensifying
safety regulations, thereby boosting the adoption rates of pharmacovigilance
systems by pharmaceutical companies.
Several countries,
including India are in the process of implementing stringent regulations for
adoption of Pharmacovigilance.
There is significant potential for outsourcing/off shoring for
mid-sized companies as well. Large number of global drug companies has starting
off shoring their pharmacovigilance activities to the markets like India. In a
typical pharmacovigilance department or specialized pharmacovigilance company,
there are several positions. Pharmacovigilance offers excellent growth
prospects.
EsPharma Education flagship program, certification in
Pharmacovigilance, is in existence for the last 2 years and over 6 batches have
passed and have been placed in the pharmaceutical companies, CROs and other
clinical research organizations. Our students have been placed with the leading
companies.
Program
Structure
·
30 – 45 days extensive training on Pharmacovigilance (PV) is
provided.
Entry Level Career
Options Upon Completion of the Program:
Ø
Pharmacovigilance Officer
Ø Drug Safety Associate
Ø Drug Safety Officer
Ø Drug Safety expert
Why EsPharma
Education?
·
Industry Accredited / Certified
·
Completely Job Oriented
·
100% placement Assistance – Excellent Placement Record
·
Training by the team of industry experts – both full time and
visiting senior faculty
·
Small batch – 10 Seats
Mode
: Classroom training
Duration
: 30-45 Days
Eligibility : MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharm,
Graduate/ Nursing, Biochemistry, and all
professionals working with Pharmaceutical companies, CROs and Hospitals.
Examination : Classroom Exams
(descriptive & Objective) Presentations, Mock interviews
Certificate : Certificate
would be awarded upon successful completion of the program.
Job Assistance : Extensive Placement support would be provided to the
successful candidates. CVs of successful candidates would be forwarded to CROs
Hospitals and Pharmaceutical companies and, Interviews would be organized.
Fee Payment : 25,000/- per
candidate
Program Details – Pharmacovigilance:
(As per Job description of the company)
·
Drug
Discovery & Development
·
Current
Good clinical Practice (E6)
·
Introduction
to Pharmacovigilance
·
History
& Definitions in Pharmacovigilance
·
Pharmacovigilance
in India and other parts of the world
·
Introduction
to ADRs
·
Reporting
Information resources in Pharmacovigilance
·
Review of
ICSRs, Acknowledgment and data entry guidelines
·
Time
lines and prioritization of ICSRs
·
Seriousness
Assessment Criteria and Causality assessments
·
Drug
dictionaries and event coding in Pharmacovigilance
·
Labeling
of SAEs in IB and Core data sheet
·
Narrative
writing
·
Online
and off-line medical review
·
Reconciliation
activities
·
Signal
detection, Risk assessment and management
·
Aggregate
& Periodic Reports
·
Tools
used in Pharmacovigilance
·
Data
entry process in the Safety database
·
Practical
session on the ICSR reporting
Wish You All The Best For Your Career
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