Drug Safety Associate

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.

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.

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

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.

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

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.

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).

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.

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.

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.

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.

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.

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.

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

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