Pharmacovigilance Writing: The Vogue in the World of Medical Writing

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.

We bridge the gap between academics and the practical skills required for medical writing.

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