1. Explain me what is causality?

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

2. Explain me what can this type of job lead on to?

It depends on the company but likely roles are other careers within Medical and Regulatory Affairs, Clinical Research, Training, Compliance and Auditing.

3. Explain me what Is The Difference Between An Ade And Adr?

There may 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.

4. Tell me what is the difference between an ADE and ADR?

There may 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.

5. What is your greatest strength as Drug Safety Associate?

This could be a very simple question if you are prepared for it. You just have to talk about the strengths that you know would be of value to the company.

6. Tell us what should a narrative consist of?

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

7. Tell me how did you begin your career in safety?

When I left university I had a short time working at the MHRA (the UK Regulatory Authority) which was a good introduction to the pharmaceutical industry. From there I went onto work within the safety departments of 2 large pharmaceutical companies.

8. Do you know what Is An Adverse Drug Reaction (adr)?

An adverse drug reaction is a “response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function.” Note that there is a causal link between a drug and an adverse drug reaction. In sum, an adverse drug reaction is harm directly caused by the drug at normal doses, during normal use.

9. Explain me what Should A Narrative Consist Of?

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

10. Explain me when do you consider a case to be medically confirmed?

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

Note: HCP can be a physician, nurse, pharmacist, coroner or psychologist (only in Germany).

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