Pharmacovigilance is a crucial element of drug advancement
and marketing. Monitoring the safety of patients and identifying the adverse
effects of drugs and their potential and benefits is a task which is highly
regulated on a global level and is continued throughout a drug’s lifecycle. The
consequences and end results of these analyses are presented to health
authorities in form of periodic aggregate reports and other pharmacovigilance
(PV) documentation like RMPs (Risk Management Plans) are in demand by
regulations all over the world.
A pharmacovigilance writer plays a very important role in
producing these documents and even managing them. An expert PV writer offers PV
expertise, comprehensive knowledge of guidelines, regulations and other
requirements, formatting, documents, content specialization, communication
& writing and skills related to project management. The presence of these
skills makes it certain that the submission of patient safety, information on
safety level of drugs, adverse effects of drugs and the analysis of risk by the
companies to the regulatory authorities are clear and steady throughout the
entire course of PV documents and that these documents are drafted on time and
in an effective and efficient fashion.
What is PV writing?
Pharmacovigilance (PV) writing focuses on each aspect of
drug development making its way from clinical trials through required report
submissions before getting authorization from the market and all the way to the
post-marketing state.
Skilled writers are in demand who can apply their functional
expertise and knowledge of clinical drug advancement to handle the technical
specifications of the documents, so the end document meets all the regulations
and guidelines.
During the phase of clinical advancement of any drug, safety
and efficacy report of the drug is required in clinical trials. The reports are
made up post determining the safety data from a considerable proportion while
it is being submitted for the marketing authorization.
PV writers are involved in writing Benefit-Risk regulatory
reports, all that while till the product is available. PV writers aim to bridge
the gap between medical health experts and the general public through their
analysis of drug efficacy and safety and thus help to build trust in patients
regarding the usage of drugs.
To sum up, pharmacovigilance writers furnish in clinical
drug advancement by offering their scientific competence in formulating the clinical
plan blueprint and structure of clinical drug advancement programs so that the
drugs can be developed accordingly for human use.
Why Choose a Career in
Pharmacovigilance Writing?
Pharmacovigilance is an
integral part of clinical research and is growing exponentially. Many PV
centers are breaking a sweat to work on drug safety control but the issue that
lies down beneath the surface is that pharmacovigilance is facing an extensive
shortage of human resources and there is a huge demand for skilled professionals.
When it comes to new drugs, one must be extremely careful as they take a long
time to reach the market following the entire regulatory course which
determines their safety and efficacy level to assure that they can receive a
market authorization.
Where can you find a job as
a PV writer?
A PV writer is hired by the
following organizations:
·
Pharma companies
·
Contract research organizations
·
BPOs/KPOs
·
Regulatory firms
·
Regulatory consultants
·
Site management organizations
·
Government Regulatory Bureaus
How can You Commence Your
Career as a PV Writer?
With the six-month diploma
course in medical writing, pharmacovigilance and market
research, offered by Turacoz Skill Development
Program (TSDP), you can rest assured to have a reliable and
competent entry into the world of pharmacovigilance writing.
The course offered by TSDP
will help you in learning:
·
Fundamentals of clinical research
·
Drug disclosure and advancement
·
Fundamentals of pharmacovigilance
·
Literature search
·
Medical jargons
·
MedDRA, etc.
The course is designed
keeping in consideration the industry standards and requirements and is taught
through a blended mode. The course focuses on making individuals industry-ready
and works beyond technical aspects to even groom them personally and
professionally.
TSDP also provides
placement and career development support. One can expect to learn all the
basics of pharmacovigilance, new
trends in PV and develop professionally to start their
career as a pharmacovigilance writer.
To register yourself for
this course, click here.
To know more about TSDP and the courses we offer, write to us at trainings@turacozskilldevelopment.org
