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Drug Safety Physician - Gratisol Labs

Drug Safety Physician/Medical Reviewer in Oracle Argus Safety Database with Practical Hands on Training with Project Experience Certification & Placement Assistance

Drug Safety Physician is a well paid, career opportunity within Pharmacovigilance organisations and is responsible for management of benefit-risk profile including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals etc. for assigned post-marketing products as well as products under clinical trials. A Drug Safety Physician is expected to demonstrate strong medical knowledge and analysis for ICSR reports, safety documents (e.g. PSURs/PBRERs, signal analysis, RSI, regulatory enquiries, risk management plans). In addition a strong knowledge regarding international regulatory requirements like ICH, European Pharmacovigilance legislation, FDA and CIOMS etc is required to be a successful Drug Safety Physician.

In the past getting training in Drug Safety (DS) and Pharmacovigilance (PV) was very difficult.  Most of it involved on the job training in the company or health agency where you worked. Most people came into it from other functions within that institution, such as a move from clinical research or medical information.

Things have changed in the last few years and I’d like to review some of the available education options available. This list is not complete. If any readers wish to add more resources by responding to this posting that would be most welcome and helpful. The attempt here is to limit the information to DS and PV rather than courses in regulatory or clinical research which touch upon (usually briefly) DS and PV.  There are many (profit-making) companies worldwide that offer one or more courses or training sessions lasting a day to several days. They are usually not primarily educational institutions. I will not attempt to examine them here but rather will look at educational institutions that are often (though not always) non-profit.

Note: I am not making any recommendations or comments on the validity, usefulness or quality of any of these courses or certificates. You should do a thorough evaluation yourself before enrolling in any course or program to see that they meet your needs and desires. In particular, the programs offered by for-profit entities should be looked at very carefully. Caveat emptor (let the buyer beware). Look at the faculty, the textbooks, the experience of the other students (and, of course, the faculty), whether the training is didactic or interactive, whether it is US, EU or other areas etc. See if it is in person or web-based and if the latter, what sort of personal interaction you will/can have with the faculty.

Finally, there are no certificates or degrees that are yet universally accepted as credentials for employment in DS or PV. Although a degree or certificate is certainly useful and praiseworthy, it is not clear that this will get you a job or necessarily enhance your ability to get a position.  There are, as of yet, no accrediting boards or academic standards to ensure that the programs are worthwhile or cover material that will be useful in the field. Doubtless this will come. We are just not there yet.

Rutgers Biopharma Educational Initiative

This is an established fully online web-based program coming out of the state university of New Jersey – Rutgers. They offer several programs including a Masters Degree in Clinical Trial Sciences with specialization tracks in four areas:

  • Clinical Trial Management & Recruitment
  • Clinical Trials Informatics
  • Regulatory Affairs
  • Drug Safety and Pharmacovigilance

They also offer certificate programs in each of these four areas.  For the DS/PV certificate the requirements are three core courses:

  • Regulatory & Ethical Requirements in Clinical Investigation
  • AE Reporting & Postmarketing Activities
  • Principles of PV, Regulations & DS Reporting

Two elective courses must also be taken amongst the following:

  • Overview of Disease Processes & Treatment
  • Risk Management Tools
  • Clinical Pharmacology or Nutrition and Pharmacology
  • Analyzing Clinical Data to Determine Adverse Events

Costs are about $1000 a credit plus various university fees. Each of the courses above is 3 credits. See this site for information on the certificate program and click on the links on the left side of the page for much more information.

Gratisol Labs

Gratisol Labs offers a 45 days course in Pharmacovigilance, Pharmacoepidemiology and Drug Safety Physician covering medical reviewer roles including hands on experience on Safety Database, MedDRA Coding & Whodrug Coding and awards a certificate.

Temple University

Temple has a program leading to a Certificate in Global PV: Risk Assessment.

The program is based in based in Fort Washington, PA and courses are scheduled on evenings and weekends and can be videoconferenced to corporate sites. Fifty courses are offered online in real time and the entire program can be done on-line per the website. Prerequisites include a Bachelor’s degree from an accredited institution. There is no information on the fees that I could find. Five courses must be completed within 4 years:

  • Post-Marketing Safety Surveillance or Clinical Drug Safety and Pharmacovigilance
  • Good Pharmacovigilance Operations
  • Pharmacoepidemiology
  • The Regulatory and Legal Basis of Pharmacovigilance
  • Risk Management and Safety Signaling of Healthcare Products

Drug Information Association (DIA)

This is a confusing website in regard to courses to be taken. They require 16 core units and 16 elective units. The core units include courses such as:

  • Adverse Event Reporting Requirements: IND and Postmarketing (online)
  • How to Prepare for a Safety Inspection (online)
  • Introduction to Signal Detection and Data Mining (online & face-to-face)
  • Postmarketing Drug Safety and Pharmacovigilance (face-to-face)
  • Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum (face-to-face)
  • Premarketing Clinical Safety and Pharmacovigilance (face-to-face)
  • Risk Management and Safety Communication Strategies (face-to-face)

There are about 15 elective courses noted some of which are online and others are held around the US.  There are also certificate programs in clinical research, project management and regulatory affairs.  DIA says most people complete the program in two years.  There is no information on the fees that I could find directly.

Full disclosure: Until last year, I was one of the instructors in several of these courses.

DIA also offers individual courses in the Horsham, PA offices as well as other sites around North America. There are DIA courses run in Europe and Asia also.  DIA also has eLearning Modules, webinars, online training and training at corporate sites.

Durham (NC) Tech

This is a new program starting in the Triangle area of North Carolina (Raleigh, Durham, Chapel Hill) at the Community College in Durham. They offer two plans of medical product safety and PV: one is a certificate associate degree and the other is a certificate program. .

The cost of the program is based upon credit hours – the current cost of a credit hour at Durham Tech is $72.50/hour. The certificate program with books and fees is approximately $1500.00.

Full disclosure: This is a new program and I am on the advisory board.

The associate degree is aimed primarily at those students who wish to obtain a two year associate degree and continue on to a Bachelor’s degree elsewhere or to obtain a job (or both).  There are twenty-one courses to take over about 2-1/2 years.

The certificate program covers five courses:

  • Introduction to Medical Product Safety
  • Medical Product Safety Regulations
  • Safety Reporting
  • Safety Systems and Processes
  • Signal Detection and Risk assessment

The certificate program can be done entirely on-line but the degree program does require attendance in Durham for some of the courses.

Other Courses & Certificates that are not primarily Drug Safety or PV

Johns Hopkins University/Bloomberg School of Public Health

JHU offers a Certificate in Pharmacoepidemiology and Drug Safety.

This is a more general series of courses covering drug development, regulatory issues, effectiveness, drug utilization and drug safety.  Twenty credits must be taken and the course must be completed in 3 years. The courses are heavy on epidemiology and seem to touch on the mechanics of drug safety more lightly. For non-Hopkins students, the requirements for entry are a baccalaureate degree and at least three years in a health field.

The University of Maryland School of Pharmacy

This university has an academic department doing research on pharmacoepidemiology and PV but does not seem to offer specific courses or certificates aimed at clinicians in the field.

The following are outside North America and the emphasis will be on EU PV and pharmacoepidemiology.  There are many others in Asia and elsewhere and you should do a google search and check websites and blogs in the country or region you wish to study.

Drug Safety Research Unit – University of Portsmouth UK

This is a well known and highly regarded unit with a long history of research and education in PV.  It offers short courses on PV usually held in Southampton (on the southern coast of England) or sometimes in London.  The emphasis is on the UK and European Union.  They also offer certificates, diplomas and a masters degree in PV. Information, including fees, can be found here.

Eu2P: European Program in PV and Pharmacoepidemiology

This is a consortium of seven universities and 15 pharmaceutical companies as well as the French health agency and the EMA.  They offer courses in PV leading to a masters degree, a PhD or certificates of which there appear to be up to 25 different ones.  The certificate programs run three months, the masters degree one to two years and the PhD three years.  The website notes the courses are designed for graduate and postgraduate students in health and life sciences, healthcare professionals and non-specialists. It appears to be primarily web-based with e1learning tools. Costs run about 3000 euros for professionals and 1500 euros for students.

The University of Bordeaux

This university offers a masters degree and certificates in Pharmacoepidemiology and PV.  See also the Eu2P site which appears to coordinate the programs.

The University of Hertfordshire UK

This university offers a masters program in PV and on their website they note that they have had students from the EU, Japan and the USA.  It appears that study is done in person in the UK.  Check their website for full details.

The University of Barcelona (Universitat Autonoma de Barcelona) Spain

This university offers a masters degree in conjunction with the coordinators at the University of Bordeaux and participating universities in Barcelona, Rotterdam, Verona, Utrecht and Hertfordshire.

Cranfield University, UK

This postgraduate university offers a masters degree in PV data management at the cost of 16,250 pounds for non-UK students and 6800 pounds for UK students.  It appears that coursework needs to be done in the UK.

London School of Hygiene and Tropical Medicine UK

This school offers a 20 week course in pharmacoepidemiology and PV and awards a certificate.

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