10+ Pharmacovigilance Associate Interview Questions and Answers for Freshers

Excipients are inactive substances added to drug formulations to aid in the manufacturing process, enhance stability, improve bioavailability, and ensure patient acceptability.

• Excipients are inert substances that are added to drug formulations.

• They are used to aid in the manufacturing process, such as binding agents, fillers, and lubricants.

• Excipients can enhance the stability of the drug, preventing degradation or chemical reactions.

• They can improve the bioavailability of th...read more

Ondom is a drug used to treat nausea and vomiting.

• Ondom is commonly prescribed to patients undergoing chemotherapy to manage chemotherapy-induced nausea and vomiting.

• It is also used to prevent and treat nausea and vomiting after surgery.

• Ondom works by blocking the action of serotonin, a natural substance in the body that can cause nausea and vomiting.

• The drug is available in various forms such as tablets, oral solution, and injectable.

• Common side effects of Ondom include head...read more

Schedule P in pharmacy refers to the list of drugs that can be sold without a prescription.

• Schedule P is a classification system used in some countries to categorize drugs that can be sold without a prescription.

• These drugs are considered safe for self-medication and are typically used to treat common ailments.

• Examples of drugs in Schedule P include over-the-counter pain relievers, cough syrups, antacids, and topical creams.

• Schedule P drugs are usually available for purchase ...read more

Pharmacovigilance ensures drug safety by monitoring adverse effects and ensuring regulatory compliance.

• Pharmacovigilance involves collecting and analyzing data on adverse drug reactions (ADRs).

• Example: Reporting a severe allergic reaction to a new medication helps assess its safety.

• Regulatory bodies like the FDA and EMA require ongoing safety monitoring post-marketing.

• Signal detection is crucial; it identifies potential safety issues from data trends.

• Example: A sudden increas...read more

An example of an antifungal drug is fluconazole.

• Fluconazole is commonly used to treat fungal infections such as candidiasis and cryptococcal meningitis.

• It belongs to the class of drugs known as azole antifungals.

• Other examples of antifungal drugs include amphotericin B, itraconazole, and terbinafine.

Pharmaceutical departments are specialized divisions within pharmaceutical companies that handle various aspects of drug development, production, quality control, and regulatory compliance.

• Pharmaceutical departments are responsible for research and development of new drugs.

• They conduct clinical trials to test the safety and efficacy of new drugs.

• Pharmaceutical departments oversee the manufacturing and production of drugs.

• They ensure quality control and adherence to regulatory...read more

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring the safety of pharmaceutical products after they have been released to the market.

• It includes collecting and analyzing data on adverse drug reactions and other drug-related problems.

• The goal of pharmacovigilance is to improve patient safety and minimize risks associated w...read more

Literature case creation criteria involve specific guidelines for identifying and documenting adverse events from published literature.

• Identification of relevant literature sources, such as journals and databases.

• Assessment of the quality and credibility of the literature.

• Determination of whether the reported event is an adverse drug reaction (ADR).

• Inclusion of sufficient patient details, such as age, gender, and medical history.

• Documentation of the drug involved, dosage, and...read more

Reporting timelines vary based on the severity and type of adverse events in pharmacovigilance.

• Serious adverse events (SAEs) must be reported within 7 days.

• Non-serious adverse events typically have a 30-day reporting timeline.

• For expedited reports, timelines can be as short as 24 hours for life-threatening cases.

• Example: A death related to a drug requires immediate reporting within 7 days.

Diabetes is a chronic condition that affects how your body turns food into energy.

• Diabetes is characterized by high levels of blood glucose resulting from defects in insulin production, insulin action, or both.

• There are three main types of diabetes: type 1, type 2, and gestational diabetes.

• Symptoms of diabetes include frequent urination, increased thirst, unexplained weight loss, and fatigue.

• Treatment for diabetes may include medication, insulin therapy, lifestyle changes, an...read more

An adverse event is an undesirable and unintended sign, symptom, or medical condition that occurs after using a medication or medical device.

• Adverse events can range from mild side effects to severe reactions.

• They can be caused by medications, vaccines, medical devices, or other healthcare interventions.

• Adverse events should be reported to regulatory authorities for monitoring and evaluation.

• Examples include nausea, headache, allergic reactions, and organ damage.

The seriousness of a case in pharmacovigilance refers to the potential impact on the patient's health if the adverse event is not addressed.

• Seriousness is determined by factors such as the outcome of the event, the patient's medical history, and the need for medical intervention.

• Examples of serious cases include hospitalization, life-threatening events, disability, and death.

• It is important to assess the seriousness of a case accurately to prioritize reporting and follow-up a...read more