Drug Safety Associate Interview Questions & Answers

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

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

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.

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.

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.

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.

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.

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.

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.

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).

Patient demographics: Age, gender and race.

Suspect product details: Drug, dose, dosage form, therapy dates, therapy duration and indication. Adverse event details: Event, event onset date, seriousness criterion, event end date and latency.

Pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines

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.

The role varies between companies but typically involves:
☛ The receipt, processing and reporting of adverse event reports
☛ Following-up with reporters to obtain further details about a case report
☛ Providing an information service to healthcare professionals and patients on product safety
☛ Providing safety expertise to internal cross-functional colleagues

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

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.

Keeping on top of the legislation- safety is highly regulated buy keeping up to date with the legislation and how it is being interpreted by industry and the various regulatory authorities is a challenge.

Speak about specifics that relate to the position you are applying for. If you do not have specific experience, get as close as you can.
If you are being asked this question from your employer then you can explain your experience. Tell the employer what responsibilities you were performing during your job. You can tell what programs you developed and what modules you worked on. What were your achievements regarding different programs.

I’m not sure anyone has ever grown up thinking that when they are older they want to work in pharmacovigilance and it was something that I fell into really. However, I enjoyed working within pharmacovigilance and it has progressed from there. The Safety role has evolved over time and working in a culture whereby we are streamlining our processes so that we can focus our energy on using safety data in the smartest, most proactive way to anticipate/identify issues has kept my interest in this area.

USA: United States Food and drug administration (USFDA).

UK: European Medicines Agency (EMEA).

Japan: Ministry of Health, Labour and Welfare (MHLW).

India: Central Drugs Standard Control Organization (CDSCO)

It is crucial that you discuss your objectives and how you intend to achieve them.

For instance: I would like to be the best in my department or I would love to be the person my colleagues can rely on. I also feel I would be skilled and experienced enough to handle whatever responsibilities might come my way.

I’m not sure there is one! For me there are two distinct parts of the safety role – the day to day part of the role (which mainly focuses on the handing of safety reports) and the cross-functional part of the role (which mainly focuses on how the safety function can add value in the cross-functional settting).
The day to day part of the role can be routine but the volume and nature of the reports we receive always presents a challenge to ensure that the reports are processed in a timely manner and to the high standards that are expected. At the same time, members of the team can be working on cross-functional projects with our colleagues in the medical affairs or sales and marketing function, or they can be working on cross-industry initiatives.

E2a: E2a guidelines give standard definitions and terminology for key aspects of clinical safety reporting. It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.

E2b: E2b guidelines for the maintenance of clinical safety data management and information about the data elements for transmission of Individual Case Safety Reports.

E2c: E2b guidelines for the maintenance of clinical safety data management and information about the Periodic Safety Update Reports for marketed drugs.

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

There are a lot of misconceptions about safety. There is part of the role which is relatively routine (e.g. collection and processing of reports) but the key is to think broadly and understand the importance of these activities in protecting patients who receive any given medicine. In addition, the key to being successful in safety is to use your safety expertise to consider how you can add value to your business and improve the understanding of the risk and benefit of a given medicine.