20+ Drug Safety Associate Interview Questions and Answers for Freshers

Clinical trials are research studies that test new treatments or interventions on humans to determine their safety and efficacy.

• Clinical trials are conducted in phases, each with a specific purpose and goal.

• Phase 1 trials involve a small group of healthy volunteers to test safety and dosage.

• Phase 2 trials involve a larger group of patients to test efficacy and side effects.

• Phase 3 trials involve an even larger group of patients to confirm efficacy and monitor adverse reaction...read more

Abbreviations commonly used in the Pharmacovigilance (PV) and clinical research field.

• PV - Pharmacovigilance

• ADR - Adverse Drug Reaction

• AE - Adverse Event

• SAE - Serious Adverse Event

• CIOMS - Council for International Organizations of Medical Sciences

• ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

• FDA - Food and Drug Administration

• EMA - European Medicines Agency

• IRB - Institutional Review Board

• GCP - Good Clinical Practice

• ICH...read more

Pharmacovigilance is essential in determining drug safety. It involves monitoring, assessing, and preventing adverse effects of drugs.

• Pharmacovigilance helps in identifying and reporting adverse drug reactions (ADRs) to regulatory authorities.

• It involves continuous monitoring of drugs even after they are approved and marketed.

• Pharmacovigilance data is used to update drug labels and inform healthcare professionals and patients about potential risks.

• It also helps in identifying...read more

Good clinical practice in Pharmacovigilance involves systematic monitoring, evaluation, and reporting of adverse drug reactions.

• Adherence to regulatory guidelines and protocols

• Timely and accurate reporting of adverse events

• Continuous monitoring of drug safety profile

• Risk management and mitigation strategies

• Collaboration with healthcare professionals and regulatory authorities

• Ensuring patient confidentiality and privacy

• Proper documentation and record-keeping

• Regular training an...read more

Anticancer drugs include chemotherapy, targeted therapy, and immunotherapy. Antibiotic resistance is when bacteria become resistant to antibiotics.

• Chemotherapy drugs: cisplatin, doxorubicin, paclitaxel

• Targeted therapy drugs: imatinib, trastuzumab, rituximab

• Immunotherapy drugs: pembrolizumab, nivolumab, ipilimumab

• Antibiotic resistance is a growing problem due to overuse and misuse of antibiotics

• It occurs when bacteria evolve to become resistant to antibiotics, making infection...read more

Pharmacology classification refers to grouping of drugs based on their chemical structure, mechanism of action, and therapeutic use. Pharmacovigilance is the science of monitoring, evaluating, and preventing adverse effects of drugs.

• Pharmacology classification is important for understanding the properties and effects of drugs.

• There are several ways to classify drugs, including by chemical structure, mechanism of action, and therapeutic use.

• Pharmacovigilance involves monitorin...read more

ICH and CGP guidelines are regulatory guidelines for drug development and clinical trials.

• ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines provide a framework for the development, registration, and post-approval of pharmaceutical products.

• CGP (Good Clinical Practice) guidelines provide a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials....read more

ADR stands for Adverse Drug Reaction and ADE stands for Adverse Drug Event.

• ADR refers to any harmful or unintended reaction to a medication, including side effects and allergic reactions.

• ADE is a broader term that encompasses any negative event related to medication use, including errors in prescribing, administering, or monitoring.

• Both ADR and ADE are important considerations in drug safety and pharmacovigilance.

• Examples of ADRs include nausea, dizziness, and rash, while exa...read more

MedDRA is a medical terminology used for coding adverse events in clinical trials. ICH GCP is a guideline for conducting clinical trials.

• MedDRA stands for Medical Dictionary for Regulatory Activities

• It is used for coding and classifying adverse events in clinical trials

• ICH GCP stands for International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - Good Clinical Practice

• It is a guideline for conducting clinical trials ...read more

ADR stands for Adverse Drug Reaction, pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems, and SAE refers to Serious Adverse Event.

• ADR refers to any harmful or unintended reaction to a drug or medication

• Pharmacovigilance involves monitoring and evaluating the safety of drugs and medical devices

• SAE is a severe or life-threatening adverse event that requires imm...read more

Causality refers to the relationship between a cause and its effect, determining if one event directly led to another.

• Causality is the principle that one event is the result of the occurrence of another event

• It involves determining if there is a direct relationship between a specific cause and its effect

• In drug safety, causality assessment is used to determine if a drug is responsible for an adverse event

• Factors like timing, dose-response relationship, and alternative explana...read more

ICSR Case Processing involves the collection, assessment, and reporting of individual case safety reports for drug safety.

• ICSR stands for Individual Case Safety Report, which documents adverse events related to drug use.

• The process includes data entry, validation, and analysis of reported adverse events.

• Example: A patient reports a severe allergic reaction after taking a medication; this is documented as an ICSR.

• Regulatory authorities require timely submission of ICSR data to...read more

LD50 is the dose of a substance that is lethal to 50% of the test population, while ED50 is the dose that produces a therapeutic effect in 50% of the population.

• LD50 is used to measure the toxicity of a substance

• ED50 is used to measure the effectiveness of a drug

• LD50 is determined through animal testing

• ED50 is determined through clinical trials

• LD50 is expressed in milligrams per kilogram of body weight

• ED50 is expressed in milligrams per kilogram of body weight

• LD50 is used to ...read more

Submission timelines for adverse events are typically based on regulatory requirements and can vary depending on the severity of the event.

• Timelines for submitting adverse events are usually defined by regulatory agencies such as the FDA or EMA.

• Serious adverse events must be reported within a shorter timeframe compared to non-serious events.

• Some countries may have specific requirements for submission timelines, so it's important to be aware of local regulations.

ICSR stands for Individual Case Safety Report, which is a document that contains information about adverse events or side effects of a drug.

• ICSR is a report that is submitted to regulatory authorities by pharmaceutical companies.

• It contains information about adverse events or side effects of a drug that have been reported by patients or healthcare professionals.

• ICSRs are an important tool for monitoring the safety of drugs and identifying potential safety concerns.

• They are us...read more

The IME list refers to the list of investigational medicinal products for monitoring safety and efficacy.

• IME stands for Investigational Medicinal Product (IMP) Management.

• The IME list is used to track drugs in clinical trials.

• It helps ensure compliance with regulatory requirements.

• Examples include new drugs undergoing Phase I, II, or III trials.

PV stands for Pharmacovigilance which is the science of detecting, assessing, and preventing adverse effects of drugs.

• PV is the process of monitoring and evaluating the safety of drugs

• It involves collecting, analyzing, and reporting adverse drug reactions

• PV helps in identifying new safety concerns and improving patient safety

• Examples of PV activities include signal detection, risk management, and safety surveillance

Criteria for a valid case in drug safety reporting

• The case must involve a suspected adverse drug reaction

• The reaction must have occurred in a patient who was exposed to the drug

• The case must be reported in a timely manner with all relevant information documented

• The information provided must be clear and complete

• The case must meet regulatory requirements for reporting

Valid Individual Case Safety Reports (ICSRs) must meet specific criteria to ensure accurate drug safety monitoring.

• 1. Patient Information: Must include identifiable patient details (e.g., age, gender).

• 2. Drug Information: Clear identification of the drug involved (e.g., name, dosage).

• 3. Adverse Event Description: Detailed account of the adverse event (e.g., type, severity).

• 4. Causality Assessment: Evaluation of the relationship between the drug and the adverse event.

• 5. Report...read more