1.1 Defining pharmacovigilance

They may vary in presentation and occurrence and are commonly divided into type A (augmented pharmaceutical response) and type B (bizarre or hypersensitivity) adverse drug reactions (3). throughout a drug’s market life. Pre-marketing safety assessment is generally limited for children.

Besides, What is the salary of pharmacovigilance?

Employees who knows Pharmacovigilance earn an average of ₹21lakhs, mostly ranging from ₹10lakhs per year to ₹50lakhs per year based on 202 profiles. The top 10% of employees earn more than ₹30lakhs per year.

Keeping this in mind, What are the four main components of pharmacovigilance? Core Capabilities: Pharmacovigilance delivers four primary capabilities to pharmaceutical companies: • Adverse Event Case Management including expedited reporting; • Aggregate Reporting; • Signal Intelligence; and • Risk Management.

What are the main areas of pharmacovigilance?


The Importance of Pharmacovigilance

  • Operations. The operations sector is the area in which life science graduates normally start their career in the industry. …
  • Surveillance. This sector mostly concentrates on risk management and signal detection jobs. …
  • Systems. …
  • Qualified Persons in Pharmacovigilance.

How many modules are there in pharmacovigilance?

The pharmacovigilance system is comprised of 5 modules.

What is the fresher salary in pharmacovigilance?

Pharmacovigilance Salaries

Job Title Salary
Fresher Pharmacovigilance salaries – 26 salaries reported
₹25,454/mo
IQVIA Pharmacovigilance salaries – 4 salaries reported ₹36,290/mo
First Student Pharmacovigilance salaries – 3 salaries reported ₹22,909/mo
Labcorp Pharmacovigilance salaries – 3 salaries reported ₹2,49,851/yr

Is pharmacovigilance a good career?

Pharmacovigilance is considered to be one of the best career option for life science and pharmacy graduates. It mainly deals with reporting and analysing of medicine side effects and ensure drugs in the market are safe and secured.

How can I join pharmacovigilance?


Some of the training programs that individuals can pursue to enter into this industry are:

  1. Professional Diploma in Pharmacovigilance & Pharmacoepidemiology.
  2. PG Diploma in Clinical Research & Pharmacovigilance.
  3. PG Diploma in Pharmacovigilance & Regulatory Affairs.
  4. PG Diploma in Pharmacovigilance & Medical Writing.

What are the 4 stages of clinical trials?


Phase 4 – Monitors public safety and potential serious adverse events.

  • Phase 1 Clinical Trial. …
  • Phase 2 Clinical Trial. …
  • Phase 3 Clinical Trial. …
  • Phase 4 Clinical Trial/Post-Market Surveillance/Report Adverse Events. …
  • How Long Does Each Clinical Trial Phase Last?

What are the steps involved in pharmacovigilance?

  • Pharmacovigilance process.
  • Pharmacovigilance Process (Stage 1): Detection.
  • Collection of Individual Case Safety Reports (ICSRs) …
  • Pharmacovigilance Process (Stage 2): Assessment. …
  • Pharmacovigilance Process (Stage 3): Understanding the drug safety profile.
  • Pharmacovigilance Process (Stage 4): Prevention of adverse effects.

What are the objectives of pharmacovigilance?

The aims of pharmacovigilance are to: — improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions; — improve public health and safety in relation to the use of medicines; — detect problems related to the use of medicines and communicate the findings in a timely …

What is the essence of pharmacovigilance?

Essentially, it is drug safety. Pharmacovigilance ensures the rigorous testing of clinical drugs to improve patient care and reduce the risk of negative side effects. Present throughout the drug lifecycle, PV certifies whether a drug works and if it is safe to use.

What is the concept of pharmacovigilance?

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use.

How many GVP modules are there?

Background to public consultation on GVP

This new guidance on good pharmacovigilance practices (GVP) is organised into Modules, and the first seven Modules on prioritised topics are now available for public consultation.

What are the GVP modules that speak about pharmacovigilance?

GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency’s website (see bullet points below Final GVP modules table).

What is GVP Module VI?

GVP Module VI: Management and Reporting of Adverse Reactions to Medicinal Products. … This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals.

What is the salary of drug inspector?

The salary structure of a drug inspector appointed by the central government could be different from the ones appointed by state governments. As per the Pay Matrix Level – 7, a drug inspector earns anywhere from INR 44,900 per months to INR 1,42,400 per month. The initial salary usually starts with INR 40,000 or above.

What is the qualification for pharmacovigilance?

The basic qualifications for a career in pharmacovigilance include undergraduate or graduate degree in pharmacy, human or veterinary medicine, nursing, biochemistry, biotechnology, microbiology or allied health sciences.

Which is better medical coding or pharmacovigilance as career?

Absolutely Pharmacovigilance because Pharmacovigilance is the best field to study about the available drugs as well as their side effects.

What is the future of pharmacovigilance?

The principal goal of pharmacovigilance is to influence safer usage of medicines. But, it faces increasing pressure to analyze more data sooner, monitor risks more broadly, and accurately report patient events globally.

Why do you want to work in pharmacovigilance?

Pharmacovigilance is an excellent employment option for pharmacy, life science, and medical graduates. … It is mainly due to the function of Pharmacovigilance professionals that the medicines in the marketplace that we consume are safe, and all those that are identified as hazardous are taken off the market.

What degree do you need for pharmacovigilance?

We’ve determined that 45.5% of pharmacovigilance safety experts have a bachelor’s degree. In terms of higher education levels, we found that 25.0% of pharmacovigilance safety experts have master’s degrees.

How is career in pharmacovigilance?

Pharmacovigilance is a great career option for life science and pharmacy graduates. … Pharmacovigilance professionals continuously monitor the safety of the drugs in clinical trials as well as the drugs already being sold in the market.

Which company is best for pharmacovigilance?


List of Pharmacovigilance Companies in India

  • COGNIZANT. TCS. SIRO CLINPHARM. …
  • I 3 GLOBAL DRUG SAFETY. SCIFORMIX. TCS. …
  • ICON. ACCENTURE. RX MD. …
  • JUBILIANT-BIOSYS. APCER, DELHI. WIPRO. I GATE PATNI COMPUTERS. …
  • KINAPSE. MSD (MERCK) I 3 GLOBAL DRUG SAFETY. GVK. …
  • LAMBDA. INC RESEARCH. APCER LIFE SCIENCES.
  • ALEMBIC. SUN PHARMA(Halol)
  • WOCKHARDT. Share: