Safety Science Analyst Interview Questions and Answers

Analgesic drugs are pain relievers that work by blocking pain signals to the brain.

• Analgesic drugs are used to relieve pain.

• They work by blocking pain signals to the brain.

• Examples include aspirin, ibuprofen, and acetaminophen.

ADR refers to adverse drug reactions while AE refers to adverse events. ADR is specific to drugs while AE is a broader term.

• ADR is a reaction caused by a drug while AE can be caused by any medical intervention or procedure.

• ADR is a known and expected side effect of a drug while AE can be unexpected and not necessarily related to the intervention.

• ADR is reported to regulatory authorities while AE can be reported to any healthcare provider.

• Examples of ADR include nausea, vomiti...read more

Clinical trials typically have four phases.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group to test effectiveness and side effects

• Phase 3: Even larger group to confirm effectiveness and monitor side effects

• Phase 4: Post-marketing studies to monitor long-term effects and compare to other treatments

ADR stands for Adverse Drug Reaction. ADE refers to Adverse Drug Event. ADR is a specific type of ADE.

• ADR is a harmful reaction to a medication that occurs at normal doses used for treatment.

• ADE is a broader term that includes any harm resulting from the use of a medication, including medication errors and adverse drug reactions.

• ADE can be intentional or unintentional, while ADR specifically refers to unintended and harmful reactions to medications.

• Example: An ADE could be a ...read more

Causality refers to the relationship between an event (the cause) and a second event (the effect), where the second event is a result of the first.

• Causality is the principle that everything has a cause and effect.

• It is the relationship between an action and its consequences.

• Causality can be used to determine the root cause of an accident or incident.

• Examples of causality include smoking causing lung cancer, or lack of sleep causing fatigue.

• Causality is important in safety sci...read more

ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

• ICH is a global organization that develops guidelines for the pharmaceutical industry.

• It aims to promote the safety, efficacy, and quality of pharmaceutical products.

• ICH guidelines cover various aspects of drug development, including clinical trials, manufacturing, and registration.

• Examples of ICH guidelines include the Common Technical Document (CTD) and Good Cl...read more

PV stands for Process Validation.

• PV is a documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes.

• It involves establishing scientific evidence that a process is capable of consistently delivering quality products.

• PV is an important aspect of quality assurance and is required by regulatory agencies in industries such as pharmaceuticals and medical devices.

• Examples of PV include testing the sterilization ...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 is the process of monitoring and evaluating the safety of drugs.

• It involves the collection, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related problems.

• Pharmacovigilance aims to improve patient safety by identifying and minimizing the risks associated with the us...read more