Pharmacovigilance system- Industry perspective, Market size and Operations

Monitoring adverse drug reaction is an essential component in patient safety. In the last decade we have seen how technology has influenced the entire healthcare system, leading to patient awareness, thus making the pharmaceutical companies and regulatory authorities to invest more time and resource in monitoring adverse events.

Pharmacovigilance as per WHO is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

Pharmacovigilance is the study of adverse events taking into account all the plausible relationship or untoward medical occurrence which the patent experienced after taking the drug and then using standard set of coordinated activities which involves first collecting adverse event reports either via telephone, email, social network, lay press , media. After adverse event reports are filed we then process and assess these reports in database to determine if indeed these adverse events related to the suspected drug, and if there a causal relationship between the drug and the event, we term them as adverse drug reaction.

 An adverse drug reaction as per WHO is a response to a drug that is noxious and unintended and occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the modifications of physiological function.

In Pharmacovigilance we take into account every untoward medical occurrence which the patient experiences after taking the drug, thus creating individual report for every patient, this report when processed in a database is assigned with unique safety identifier number which is a unique number for every patient identifier and is called as an individual case safety report (ICSR) and the function of processing and medically assessing an iCSR is called Case Processing.

With new drugs, especially generics mushrooming into pharmaceutical market which are less expensive, there have been several reports seen on counterfeit medication being sold and administered, this illicit use of drug has led to growing patient awareness and with the availability of cloud based services for reporting ADR and the regulatory compliance for electronic submission of adverse event reports, we have seen a surge adverse event reports from various spontaneous sources to be processed, thus creating a huge demand for case processing in the pharmacovigilance industry.

Market Size 

On a recent study conducted for assessing the market trend in pharmacovigilance, it was estimated that market size would witness an exponential growth 10.7% CAGR from 2016 to 2024.

The current market size in United States is valued over 1 Billion USD, Asia- pacific at over 835 million USD and Europe at over 793 million USD.

Career pathing in Pharmacovigilance

Pharmacovigilance is diversified field with excellent growth opportunities, when discussing about career pathing, one must be first made aware about services in pharmacovigilance. ‘A service may be defined here as anything that adds value to a product, it may technology, regulation, infrastructure etc.…’ Which makes us to roll back to understand definition of pharmacovigilance from an industry perspective which states that it is a science which involves a series of activities, or we may now call them as ‘workflows’ in pharmacovigilance. The workflow described in the definition includes:

1.Collection and reporting team: Adverse event reports may be collected from spontaneous sources via telephone, fax, email or form solicited sources which includes clinical trial, patient registries.There are career opportunities in pharmacovigilance to be a part of this dedicated workforce which would responsible for only collecting reports. As pharmacovigilance activities are operated from corporate workspace. Bands are denoted for every designation and the team involved in collection of adverse event reports comprises of Local Pharmacovigilance Officers, Pharmacovigilance Associate, Drug Safety Analyst    are denoted with band AA or Associate.

2. After the reports are collected : we then need to process these reports in safety databases as per regulatory requirements for electronic transmission as E2B files, which takes us to our next service in pharmacovigilance called Case Processing.Case processing involves different workflows and each workflow is in itself a service.Book In / Case Entry workflow: After we receive the adverse event reports, we need to do duplicate check, to ensure that there are no duplicates of the same report present in the database, the Book In team then creates a case assigning a unique safety identifier number.

3.The Book In team then routes the case to the next workflow, which is Data Entry.

Data Entry Workflow:  The data entry ensures that the information from the source documents are updated in the safety databases without any discrepancy, Data entry team are also responsible for preparing case narratives and conducting follow up activities with health care professionals and consumers for obtaining more information about the adverse event.

The Book In team and the Data Entry comprises of Pharmacovigilance Associates or Junior Data Analyst.The entry qualification for a Pharmacovigilance Associate would be B. Pharmacy, B.H.M.S, Bachelor of Physiotherapy, BDS and B.A.M.S

The average salary for an Associate would be between Rs.15,000- Rs.25,000 per month

4.After Data Entry is completed the cases is routed to the Quality Review/ Primary Review workflow where the case is checked for discrepancy.

Quality Review Workflow: The quality review team would systematically review each field and check the data with source document to ensure good quality data is generated.

The Quality review team comprises of Senior Associates. The average salary for a Sr. Associate would be between Rs.20,000- Rs.35,000 per month.

5.From Primary review the case is routed to Medical Review, where medical assessment for ISCR is done.

Medical Review Workflow: The medical evaluation team assess the causal relationship between the drug and the event to see whether adverse event is related or not using related with help of clinical assessment by understanding the pharmacology of the drug and pathophysiology of the disease and substantiating the evidence with the help of causality scales of assessment.

The Medical review team comprises of Drug Safety Physicians. The entry qualification for a Drug Safety Physicians would be M.B.B.S. The average salary for a Drug Safety Physicians would be between Rs.35, 000- Rs.80, 000 per month.

6.After the case evaluated and the causal link is confirm, it is then archived for regulatory submissions.

Distribution Workflow: The cases are archived and validated. A team checks for all validation errors and then submits the files as E2B to regulatory authority.

The Distribution team comprises of Senior Associates.

 Aggregate reporting team

After the case has been processed. For a Marketing Authorization Holder or a Pharmaceutical company it is essential to study safety profile of the drug, for which need to have a consolidated report. Aggregate reporting is yet another service which offers this.

Aggregate reports are of two types Pre Approval reports prepared during the clinical trials, which include Developmental safety update reports, End of study reports, Annual Safety reports and Suspected Unexpected serious adverse reaction reports with each aggregate report writing being a service in itself, further Post Approval reports prepared during the post marketing surveillance or after the drug has been granted an approval to be marketed in any specific country. Post approval reports include Periodic safety update reports or Periodic benefit risk evaluation report, Periodic adverse drug experience report, Summary bridging reports, Ad Hoc reports with each aggregate report writing being a service in itself.

The Aggregate report writing team comprises of Senior Associates.

Transition to from drug safety associate to first line management

The transition from being an Associate to Senior Associate takes place within twelve months to fourteen months, following which after two years all senior associates are eligible to become first line managers or team lead with band level B1 and salary increment is expected to be 30%  to 50 % on the cost to company value.

After four years in the pharmacovigilance setup team leads become eligible for mid-level management or Assistant Managers with band level B2. From Assistant Manager one would be eligible as Deputy Manager after another three years in the industry with Band level B3.

Deputy Manager have the overall responsibility business development and operation management.

An Operation Manager with band level C would be head of the project and would be reporting directly to the General Manager/ Vice President/ Managing Director or the Chairman.

By:

Joseph Mathew

Senior Manager-Think i

+91-9560102587

medical@thinki.in

www.thinki.in

Think-I - an organization providing technological solutions and result oriented quality services in Pharmacovigilance, Clinical Trials, Medical Writing, Drug Regulatory Affairs and Human Resources.

We provide cloud based software solutions for pharmacovigilance which are not only cost effective and user friendly but also fully validated for quick, easy import, entry and electronic submissions of adverse event.