USA & Canada Pharmacovigilance Scope and Future Growth

Pharmacovigilance (PV) is the Science & Activities related to the Detection, Assessment, Understanding & Prevention of adverse effects or medicine related to any problem as defined by the World Health Organization.
It is an essential function with the primary goal to ensure the safety of patients with the use of pharmaceuticals, including biologics, such as vaccines, plasma-derived therapies, and/or medical devices.

Frequently Asked Questions on USA & Canada Pharmacovigilance Scope and Future Growth

USA – Food & Drug Administration
Canada – Health Canada

The Canada Vigilance Program is Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada, which enables Health Canada to monitor the safety profile of health products once they are marketed to ensure that the benefits of the products continue to outweigh the risks.
Adverse reaction reports are submitted by health professionals and consumers on a voluntary basis, either directly to Health Canada or via Market Authorization Holders. The information collected by the program can be accessed through the Canada Vigilance Online Database.

One has to constantly adapt to a rapidly evolving regulatory landscape in Pharmacovigilance, and hence, therefore, the role of regulatory guidance cannot be ignored. These demands require constant training of not only current PV experts but also for the recruitment and training of experts for the future.

You will be trained with all the necessary regulatory guidance as part of the Pharmacovigilance course. The course is designed in such a way that it not only takes you through general guidance requirement, which applies to all countries, but it focuses on country-specific regulatory requirements to understand the process for the specific Country. For example: If you are from the USA, Australia, Europe, or Canada, you will be studying FDA, TGA, EMA, or Health Canada guidance, respectively. This is needed since most PV practices are guided by local and regional healthcare systems and regulations, as well as international regulations.

This two-month program helps you to better understand the fundamental principles of PV, including major regulatory authority’s laws, regulations, and guidelines, with a special focus on practical aspects so that you are thorough with the way the industry functions.

This PV training course is designed to meet the needs of those involved in any PV aspect to help you comply with your country-specific requirements.
At the end of the course, candidates will be expected to be thorough with Introduction to PV, PV Methodologies, Different Sources, Country specific Forms to report, PV regulations and PV practices, ADR reporting, safety reporting activities, aggregate reporting, signal detection, post-marketing compliance for safety monitoring, Safety database, Coding dictionary, Narrative Writing, Special scenario cases, inspections, and audits.

One can opt for performing project work in BCRI. Project programs can be offered to provide an opportunity to learn the way the industry functions in Pharmacovigilance. You will be assigned a one-month project that allows you to work under Industry professionals.
The project guide with real-time industry experience in conducting the project will assist you in learning the process and also performing it independently. The student benefits from mentorship and needs to present their perspectives at the end of the program.
The project will parallel the same activities conducted in real-time PV organizations. Applications and opportunities for PV Project programs are found on the BCRI website.

Various positions are available in Pharmacovigilance in these countries. Different Job sites will readily support this fact. Although some of them require medical background, many others don’t. The positions require a scientific experience for proper reading and understanding of the hospitals’ and patients’ records, FDA reports, Health Canada reports, medical literature, etc.
Drug Safety Associate, Narrative Report Writing, Drug Safety Scientist, Drug Safety Officer, Drug Safety Medical Writer, and Drug Safety Manager are examples of pharmacovigilance positions/jobs.

  • Drug safety or Pharmacovigilance scientist (specialist or associate)
  • Senior Drug Safety scientist (specialist or associate)
  • Drug safety or PV manager
  • Safety or PV reviewer
  • Pharmacovigilance Quality Compliance
  • Clinical Quality Specialist
  • Medical Safety scientist/specialist/reviewer
  • Country-specific Local safety officer
  • Clinical trial project safety associate (reviewer or specialist)
  • MedDRA coder
  • Pharmacovigilance safety and analytics reporting analyst/specialist/associate
  • Pharmacovigilance Auditor or PV Inspection readiness officer
  • Safety or Pharmacovigilance Physician (medical director, MD/MBBS, IMG)
  • Safety Compliance Writer
  • Good PV Practices manager
  • GCP specialist
  • Pharmacovigilance vendor
  • Case processing specialist
  • Clinical trial case processing safety specialist
  • Post-marketing case processing safety specialist
  • Epidemiology safety associate (MPH)
  • Risk management manager
  • Signal management specialist
  • Periodic reporting specialist
  • Regulatory affairs safety specialist
  • Validation specialist
  • Safety Data Exchange Agreement Writer
  • Submission Reviewer

Let’s sneak a peek into the average salaries of these positions in the US and Canada. The below figure is based on talent.com 2022 update.

Drug Safety AssociateThe average salary in the USThe average salary in Canada
The average salary per year$71,116 / yrCA$76K / yr
Medical/Scientific/Narrative WriterThe average salary in the USThe average salary in Canada
The average salary per year$72,657 / yrCA$54K / yr

The average pharmacovigilance salary in the USA is $106,275 per year or $54.50 per hour. Entry-level positions start at $68,006 per year, while most experienced workers make up to $175,500 per year.

USA Pharmacovigilance: salaries per region

  • New York: $175,000
  • Massachusetts: $146,250
  • California: $123,828
  • Illinois: $116,513
  • Colorado: $100,000
  • New Jersey: $95,550
  • Pennsylvania: $95,000
  • Maryland: $72,000
  • Missouri: $58,500

Pharmacovigilance Salaries in Canada are approximately CA$1,01,914 per yr.

  • ACROSS Global
  • Allphase Clinical Research
  • Altasciences
  • Axon
  • Biotrial
  • Canadian Centre for Clinical Trials (CCCT)
  • CATO Research
  • Celerion
  • Charles River Laboratories
  • CMX Research Inc.
  • Dicentra
  • Emergo Group
  • Ethica CRO
  • ICON
  • Innovaderm
  • JSS Medical Research
  • Keyrus Life Science
  • PPD
  • PSI
  • SGS
  • Syneos Health
  • Syreon
  • TRIO
  • Vantage BioTrials

Undoubtedly being one of the major ICH countries and developed one in the world, the United States of America has some of the top clinical research organizations. Here is the list of some of the Best Clinical Research Organizations in the USA.

The market is projected to grow from USD 6.28 billion in 2021 to USD 14.85 billion in 2028 at a CAGR of 13.1% in the 2021-2028 period.

Pharmacovigilance has spread its horizon for both products which are yet to be marketed and products which are already marketed. This includes products that are in clinical development or the post-marketing setting.

Pharmacovigilance activities require highly skilled clinical experts from various disciplines (e.g., medicine, pharmacy, pharmaceutical sciences, life sciences, biostatistics, informatics, epidemiology) and other cross-functions worldwide.

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