Drug Safety and Pharmacovigilance Training Online

About Drug Safety and Pharmacovigilance

Drug safety is one of the stages during the drug development process, particularly regarding the new medication approval or withdraws from the market. It highlights the impacts on a patient's health.

Pharmacovigilance (PV) is pharmaceutical science which deals with the multiple steps like data collection, detection, assessment, monitoring and prevention of the adverse effects caused by the usage of the pharmaceutical products given to the patients.

Drug safety and Pharmacovigilance both refer to the same functionality. Drug safety is monitoring of drug towards compliance during clinical trials, where Pharmacovigilance relates to control of drug post-marketing stage. During the clinical trials, the drug side effects data is initially obtained only from a few sets of voluntaries/ patients (for example, like 5,000 to 10,000 patients). On the other hand, Pharmacovigilance deals with real-time scenarios in various health care centers in different regions to know more about the side effects.

The Pharmacovigilance professionals monitor the safety of the drug during the testing phase known as clinical trials. Also, they do follow even after the drug enters the market.  Signals are identified by drug monitoring before and after entering into the market. A signal is defined as a new potential cause from one or multiple sources are reported. Whenever a side effect reported, the pharmacovigilance professionals enter the reported side effect into a relevant database of each drug; also they follow up with the reported case to gather more relevant information and prepares a detailed report. The detailed reports forwarded to the regulatory authorities who monitor the drugs and their safety. The pharmacovigilance professionals also analyze the case and check the side effects, which may have some potential.

Objective

The main objectives of PV/Drug safety are -

a) Statistically quantify Adverse drug reactions

b) Identify unexpected Adverse drug events

c) Evaluate the effectiveness of drugs

d) Reduce the mortality and unwanted risks associated with the use of pharmaceutical products.

Signal and its importance in PV

Signal detection and its assessment play an essential role in Pharmacovigilance, which ensures the safety of the drugs' usage by the patients. The adverse reactions detected during clinical trials (as a part of drug safety)provide limited information obtained from a limited number of volunteers/patients who are treated and observed  in a controlled environment but the unexpected and unknown signals are identified only in the post-marketing phase of the drug, and this becomes a significant challenge in Pharmacovigilance. The primary function of Pharmacovigilance is to detect these signals as early as possible.

WHO (World Health Organization) defines a Signal as reported information/data on a possible causal link/association between an adverse event and a drug, of which the link is unknown or incompletely documented previously.

Signal assessment is done based on the quality and seriousness of the Adverse events reported — the collation of the signals done by using various databases and the software available in the market. The databases used vary for the country as per their regulatory authorities. For example, US- AERS (Adverse Event Reporting System) which is  knows as database that have data of adverse event and medication error reports submitted to FDA (Food and Drug Administration), Europe- EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) known as European data processing network and management system used in reporting and evaluation during new drugs development for suspected adverse reactions and for following the marketing authorization of medicinal products in European Economic Area (EEA) ,Vigiflow- India ,etc.

Data Processing Cycle in Drug Safety and Pharmacovigilance

• Data Collection
• Data Entry
• Adverse Event Coding
• Drug/Medical Coding
• Causality
• Assessment
• Narrative Writing
• Quality Control
• Report Submission
• Data Storage and Maintenance

What do you learn during training?

• Good Clinical Practices during Clinical Trials
• Drug Development Stages
• Adverse events and effects and how to handle?
• What is Signal and how to identify?
• Database /Software’s Usage (Oracle Argus Safety Applications, ARIS-g, Clin Trial, Macro, etc.)
• Data collection and handling
• Data entry which includes event coding, drug coding.
• Data analysis
• Data storage and maintenance
• Report preparation and submission
• Case Studies processing and Discussions
• Follow up of case studies with higher authorities
• Knowledge of Regulatory Authorities across the world and their processes (FDA, MHRA, TGA, CDSCO, EMEA)
• Handling safety and security of case profiles

Career Enhancement

Drug safety and Pharmacovigilance is a booming career option for pharmacy as well as life science graduates where they get to work on the real-time case studies/scenarios. It shows an exciting career path that strives towards the safety of the human lives and primarily working on analyzing and reporting of the drug side effects.

Trained pharmacovigilance individuals have their career path as follows –

• Drug Safety Associate
• Case Processing Expert
• Drug Safety Scientist
• Team Manager
• Associate Director
• Director

Qualified individuals in Pharmacovigilance have a lot of opportunities in multiple sectors. Mentioned below are some of the industries  –

• Biotech Companies & Pharmaceutical Companies (Multinational Companies in the US and abroad)
• KPOs (Knowledge Process Outsourcing) like Quintiles and Paraxel
• Organizations who do Clinical Research
• Hospitals and Medical colleges who have Pharmacovigilance units
• Regulatory Agencies like FDA &CDER

Also, there are more than 100+ companies who are ready to hire the individuals trained in Pharmacovigilance and some of the major companies  –

Abbott Laboratories, Accredo Health, Inc., Digestive Care, Inc, Discovery Laboratories, Inc., Dr. Reddy's Laboratories, Inc., EUSA Pharma Corporate Offices, USA, Forest Pharmaceuticals, Inc., GlaxoSmithKline, Helix BioPharma Corp., ISTA Pharmaceuticals, Inc., Johnson & Johnson,  NovaDel Pharma, Inc., Novartis Corporation, Novo Nordisk, Inc., OncoGenex Pharmaceuticals, Othera Pharmaceuticals, Inc., Pfizer, Inc., The Procter & Gamble Company, Quintiles, Ranbaxy Pharmaceuticals, Inc., Salix Pharmaceuticals, Ltd., Takeda Pharmaceuticals North America, Inc., UCB, Inc., Upsher-Smith Laboratories, Inc., URL Pharma, Inc., Watson Pharmaceuticals, Inc., Wockhardt USA, Wyeth,Xanodyne Pharmaceuticals, Inc., Zogenix, Inc., Zydus Pharmaceuticals

The average salary of a Pharmacovigilance in the USA is approx. $110K Per Annum or an average of $50K per hour. Entry-level of a job start at $50K Per Annum, and experienced employees make up to $200K per annum (Differs with different regions).

Eligibility:

Postgraduate or Graduate degree in Pharmaceutical science/Nursing/Life Sciences is required to enter the drug safety or Pharmacovigilance training program.