Pharmacovigilance  – Interview Questions

Gratisol Labs is an expert in providing Clinical research & Pharmacovigilance services for life science companies in search of personnel for clinical trials. For over 10 years, we have established a reputation among employers as one of the leading clinical recruitment agencies in Europe, the USA and Asia Pacific, delivering professional staffing and recruitment services for the global life science industry. Our team of clinical research recruiters are experts who specialise exclusively in clinical roles, sourcing exceptional clinical research CVs for contract and permanent jobs and executive search projects.

Pharmacovigilance  – Oracle Argus Safety Database Interview Questions

1. Define Pharmacovigilance?

Pharmacovigilance is defined as science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the contrary effects of medications, biological products, herbalism and other medicine.

2. What are the Minimum Criterion Required For A Valid Case?

• An identifiable reporter
• An identifiable patient
• A suspect product
• An adverse drug event

3. Define Adverse Drug Event (ade)?

Any unfortunate medical occurrence in a patient or clinical investigation subject directed a pharmaceutical product and which does not essentially have a causal relationship with this treatment.

4. Define Adverse Drug Reaction (adr)?

An adverse drug reaction is defined as a “response to a drug which is poisonous and unintended and which happens at doses normally used for prophylaxis, diagnosis  of disease.”

5. What Is the Difference Between Ade And Adr?

There is not be a causal relationship between a drug and an ADE, whereas, there is a causal link between a drug and an adverse drug reaction.

6. Define volume 9a?

Volume 9A brings together general guidelines on the requirements, procedures, roles and activities in the field of pharmacovigilance, for both Marketing Authorisation Holders (MAH) and Competent Authorities of medicinal products for human use; it combines international agreements reached within the International Conference on Harmonisation (ICH) framework.

Volume 9A is presented in four parts:

• Part I – Guidelines for Marketing Authorisation Holders;
• Part II – Guidelines for Competent Authorities and the Agency;
• Part III – Guidelines for the electronic exchange of pharmacovigilance in the EU
• Part IV – Guidelines on pharmacovigilance communication

7. When should you Consider A Case To Be Medically Confirmed?

A case is considered to be medically confirmed if it contains at least a single event confirmed or reported by an HCP (Health Care Professional).

8. What is meant By Causality?

Causality is defined as a relationship between a set of factors. In Pharmacovigilance, causality means the relationship between the suspect product and the adverse drug event.

9. Mention Some Data Elements In Icsr?

Patient demographics: Age, gender and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication.

10. What Should A Narrative Comprise?

A narrative consist of precise and concise information about the source of report, patient demographics, patient’s medical history, suspect product details and adverse event details in an orderly manner.

11. Define Meddra?

Medical Dictionary for Regulatory Activities.

12. Mention The Hierarchy In Meddra?

• System Organ Class (SOC)
• High Level Group Term (HLGT)
• High Level Term (HLT)
• Preferred Term (PT)
• Lower Level Term (LLT)

CAREER PATH

The Drug safety specialist certification course with the help of expert professionals training is recognized across the globe. Because of the increased adoption of the Argus technology in various small and large pharmaceutical companies the participants are able to find the job opportunity easily. The leading companies hire Drug safety specialist to provide the most complete case data management and regulate reporting which gains productivity in the pharmaceutical firms. The Drug safety specialist can pursue a wide range of career paths.

The following are the job titles:

• Consultant – Argus Safety Configuration
• Drug Safety Associate
• Medical Reviewer
• Pharmacovigilance officer
• Drug safety data manager
• Pharmacovigilance scientist
• Risk management specialist

Frequently Asked Questions by Drug Safety Associates:

Will the Pharmacovigilance course provided by Gratisol Labs helps me clear the Oracle Argus Safety certification exam?

This course is specifically designed to help you clear the certification exam successfully. The comprehensive content of the course along with demonstration of practical scenarios & examples will make you understand each and every topic in great depth. Since the course structure has a special focus on certification, hence you will go through a lot of real-time case studies and study material during the training that will help you crack the certification exam.

Which is better – Self-paced training or Instructor-led training?

Both self-paced training and online instructor-led training have their own advantages and disadvantages. 1) Suitability – If you have no idea about the course content and have no experience on it, then online instructor-led training will help you understand the course content better and deeply. 2) Flexibility – Self-paced training is generally more flexible than the tutor-led training since you can learn at your own pace through the videos as and when you have time. 3) Doubt-clearing, assignments etc. – You can attempt assignments and get feedback from the tutor in instructor-led training and also can get your doubts cleared during the class. Cost (more for instructor-led training) and other factors are also important.

Who are the trainers?

We have a highly qualified and experienced team of professionals who are experts in their fields. Our trainers are highly supportive and render a friendly learning environment to the students focusing on their career growth.

What if I miss a class?

In normal circumstances the tutor should be able to reschedule the class as per your convenient time but if you accidentally miss any particular class in a multi-student batch then you can catch-up from the corresponding session recording that will be shared with all students or you can request the tutor to hold a separate class for you later on the topics covered in that class.

How will I execute the practical?

We provide server access for you to practice on and our trainers will ensure that you get practical real-time experience and training with all the utilities required for in-depth understanding of the course.

Is the course material accessible after completion of the course?

Yes. We provide lifetime access to Gratisol Labs Learning Management System where you can view the course material anytime.

Is there any offer/discount that I can avail?

Yes. We have special offer/discount on this course. Please send email to info@gratisol.com asking for the discount and our team will be glad to help you.

Will I get a refund if I cancel my enrollment?

Yes. Please check our refunds and cancellation policy (link given in the footer of our website) for more details.

What if I have queries after completion of the course?

You can send an email to info@gratisol.com and our team will respond and arrange a session to clear your queries.

Why Gratisol Labs

• Study Material, E-Books, Notes, Assignments
• Real-Time Projects & Assignments
• Resume & Interview Preparation Services
• Certificate & Badge Of Course Completion
• Access to our Learning Management Systems