What is Pharmacovigilance?
WHO defined Pharmacovigilance as ‘the pharmacological science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem‘. It focuses primarily on adverse medication reactions, to put it simply. It also addresses medical blunders such overdosing, misusing, and abusing a certain medicine. These precautions are made to prevent certain harmful effects in a patient.
After information is gathered from dependable sources, such as patients, healthcare professionals, and medical literature, pharmacovigilance services are effective. This information is crucial for providing accurate results while testing new medications and examining the side effects of ones that already exist. Pharmacovigilance will focus on two primary issues in the future. Identification of the dangers connected to pharmaceutical products is the first. The second is to reduce the damage that any medications may do.
Aim of Pharmacovigilance
- Early detection of unknown safety problems
- Detection of increases in frequency
- Identification of risk factors
- Quantifying risks
- Preventing patients from being affected unnecessarily
Importance of Pharmacovigilance
- Drugs appear to be safe and well-tolerated, but the safety in the ‘real world’ is unclear. Chronically/repeatedly use of drugs and use with other drugs
- Safety in vulnerable groups is unknown Pregnant women & brestfeeding mother, elderly, young children
- Significant harm to a few patients, rumours and myths can destroy the credibility, adherence to and success of a treatment.
- Pharmacovigilance provide evidence in medicine-related problems : treatment failure, counterfeit/poor quality medicines, drug interactions, incorrect use.
- Generate evidence that will inspire public confidence and trust.
- Pharmacovigilance systems is strongly recommended – Is system of reporting exists? or capacity for monitoring?
How to Pursue a career in Pharmacovigilance
Applicants can follow this field if they have a degree in pharmacy or a life science, such as biotechnology, microbiology, biochemistry, zoology, botany, genetics, etc. Chemistry is a subject that can be studied in pharmacovigilance programmes at the undergraduate or graduate levels. Nonetheless, the minimum necessary score is 50% overall.
Pharmacovigilance Courses
One can enrol in a pharmacovigilance-related certificate or diploma programme after graduating. For those who are interested, there are numerous certificate programmes accessible. The length varies from course to course, though. The Institute of Clinical Research India (ICRI), which has locations all over the nation, provides pharmacovigilance diploma programmes. Pharmacovigilance executive diploma and one-year postgraduate diploma programmes are both offered by the Faculty of Clinical Research (FCR). One of the top programmes is the Professional Certificate in Pharmacovigilance provided by Catalyst Clinical Services. Job Oriented programmes in Udemy, Cliniindia, Cliniminds, Clininfotech etc.
Role of Pharmacovigilance
At different phases of the process of discovering and developing new drugs, pharmacovigilance is extremely important. Further safety discoveries and analyses of the dangers and advantages are required as a result of further investigation into all the adverse incidents. After the medicine is sold on the market, it continues to be crucial. Several safety evaluations are conducted, including the Risk Management Plan, Periodic Benefit Risk Evaluation Report, Development Safety Update Report, Periodic Safety Updates Report, Post Marketing Surveillances, Clinical Trials, and Pharmacoepidemiological Studies.
A new treatment must be introduced to patients through a time- and money-consuming process. As a result, monitoring the drugs’ efficacy and safety is necessary. Consequently, in order to improve medication development, it is essential to set up good pharmacovigilance methods. In order to suit patients’ medical demands, this is accomplished in order to offer them with safe and efficient medications.
Scope of Pharmacovigilance
Pharmacovigilance services are required in every nation. The distinction in the frequency of adverse drug responses and other drug-related issues in many nations is the cause. This might be brought on by variations in:
- Pharmaceutical Quality
- Compositions of local produced pharmaceutical products
- Usage of medicines in terms of dosage
- Availability of medicines
- Production of medicines
- Usage of herbal remedies that may pose toxicological problems when utilized alone or in combination with other medicines.
Responsibilities in Pharmacovigilance Job
- Examining the biomedical literature and published papers to see if there are any individual case reports or non-specific case reports.
- Using internal and regulatory guidelines to assess if the article satisfies the criteria for both legitimate case reports and non-individual case reports.
- Create succinct summaries of these public reports that are factual and include the most important details.
- Make sure words for medical history, medications, and adverse events are consistently coded.
- Assessment of Severe Adverse Event with emphasis on timeliness and quality, ensuring proper processing from source documents
- Producing summary content in a variety of formats (narrative summaries, structured database inputs, electronic formats for regulatory filing), in order to serve a client in the pharmaceutical industry’s reporting and information needs.
Career Prospects in Pharmacovigilance
As medication development and safety procedures are carried out on time, students can be sure that they will find employment in a variety of pharmaceutical organisations. A job in pharmacovigilance has good prospects because professionals can grow in their careers and receive competitive pay packages. Following successful completion of the pharmacy courses, trainees have good employment options in the following fields:
- Regulatory Agencies like DCG and CDSCO
- Medical colleges and hospitals
- Pharmaceutical companies
- Clinical research organizations
The Future of Pharmacovigilance
Because it is necessary to monitor adverse reactions across a range of medications, the pharmacovigilance sector is expanding quickly. According to a recent analysis, the pharmacovigilance industry is anticipated to grow to USD 6.1 billion in 2020 and USD 8.33 billion in 2025. Also, the pharmacovigilance market is anticipated to grow at a CAGR of over 12.8% over the forecast period of 2019–2026 and reach a market value of approximately 10.6 billion USD by the year 2026, according to a market research analysis.
Strict drug safety laws and government policies are a major driver of the growth of the pharmacovigilance market. In addition, the rising incidence of negative drug responses has resulted in a significant number of fatalities each year. These unfavourable reactions also account for 5% of all hospitalisations. Because nations must find ways to prevent these negative medication effects, pharmacovigilance has a broad scope. In addition, the elderly population base and rise in chronic diseases have increased need for pharmacovigilance services.
In the near future, a number of obstacles in the area of medication safety and regulation must be overcome. To begin with, the COVID-19 pandemic demonstrated the importance of pharmacovigilance and appropriate risk communication during times of public health emergency. Second, opportunities for improving medication benefit-risk profile evaluation in real-world settings are presented by the development of advanced methodology, including machine learning approaches, and by the availability of enormous amounts of electronic healthcare data. Last but not least, new treatments have been marketed more frequently in recent years, frequently following accelerated pathway approval. Examples include advanced therapy medical goods, digital medicines, and vaccines developed using sophisticated technologies.
Salary in Pharmacovigilance Job
Jobs are becoming more and more prevalent in India. The explanation is that drug safety is receiving more attention internationally. Salary for new hires ranges from 2.8 to 4.2 lakhs per year. A professional may therefore earn a starting salary of between 5 and 8 lakh rupees annually.
Best Companies for Pharmacovigilance Job
- BENGALURU:
- QUINTILES
- SYNOWLEDGE PV SERVICES
- BIOCON
- ACCENTURE
- ASTRAZENECA
- BLUEFISH
- SCIFORMIX/STRIDES ACROLABS
- MMS-HOLDING
- NORWICH CLINICAL SERVICES
- HCL
- OMNICARE CLINICAL RESEARCH
- MICRO LABS
- ECRON ACUNOVA
- G7 INFOTECH
- IMS HEALTH
- KINAPSE
- FORTIS HEALTH CARE
- NOVO NORDISK
- PHARMALEAF
- BIOCAD
- iMEDGlobal,
- PPDi,
- 4C Pharma Solutions
- Syngene
PUNE:
- I3 GLOBAL DRUG SAFETY
- SCIFORMIX.
- TCS
- EMCURE
- SP softtech
- CREST.
- Infocorp Software Solutions
- WIPRO
DELHI:
- JUBILIANT-BIOSYS
- APCER, DELHI
- WIPRO
- I GATE PATNI COMPUTERS
- APC PHARMA
- MANKIND
- IMS gurgaon
- SYNOGEN
- BESTOCHEM
- Symogen Limited
CHENNAI:
- ICON
- ACCENTURE
- RX MD
- TAKE SOLUTIONS
- TCS
- COGNIZANT
- EMCURE
- INVENTIVE
- i3
- IPLEX
MUMBAI:
- COGNIZANT
- TCS
- SIRO CLINPHARM
- MEDPACE
- SCIFORMIX
- PPD
- SYMOGEN
- IPCA LABORATORIES
- RATIOPHARM
- DIAGNOSEARCH
- UNIJULES (NAG PUR)
- FDC
- ABBOTT
- USV LIMITED
- PIRAMIL
HYDERABAD:
- NOVARTIS
- PARAXEL
- MAKROCARE
- MAHINDRA SATYAMBSG
- DR REDDY’S
- AUROBINDO
- SRISTEK
- SHANTHA BIOTECHNICS
- NEKTAR THERAPEUTICS
- VIMTA LABS
- BIOLOGICAL E. LTD
- MEDHIMALAYAS
- SRI KRISHNA PHARMA
- LAURUS LABS
- SANTHA BIOTECH
- PIRAMAL
- GENPACT
- INVENTIVE
- GRANULES
GURGOAN:
- KINAPSE
- MSD (MERCK)
- I3 GLOBAL DRUG SAFETY
- GVK
- WNS
AHMEDABAD:
- LAMBDA
- INC RESEARCH
- APCER LIFE SCIENCES
KOLKATA:
- WIPRO
- TCS
- COGNIZANT
VADODARA:
- ALEMBIC
- SUN PHARMA(Halol)
AURANGABAD:
- WOCKHARDT
-
<<<<<<<<<<<<< MUST READ >>>>>>>>>>>>>>
Inside the World of Drug Regulatory Affairs: Key Insights and Responsibilities Read Mastering Medical Communication: The Art of Being a Medical Writer Read <<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>
Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here Follow us on Instagram Click Here Download PHARMACY INDIA MOBILE APP from Google Play Store Click Here Follow us on LinkedIn Click Here
