Safety Science Analyst

Safety Science Analyst Interview Questions and Answers

Updated 15 Oct 2024

Q1. 3. what are analgesic drugs? MOA ? example?

Ans.

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.

Q2. What is difference between ADR &AE

Ans.

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

Q3. What phases in clinical trial

Ans.

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

Q4. What is ADR, difference between ADE and ADR

Ans.

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

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Q5. 2. why is pv important?

Ans.

PV is important for identifying and managing potential risks in various industries.

  • PV stands for pharmacovigilance, which is crucial in the pharmaceutical industry for monitoring the safety of drugs.

  • PV is also important in other industries such as aviation, where it helps identify potential safety hazards and prevent accidents.

  • PV involves collecting, analyzing, and evaluating data on adverse events and taking appropriate measures to minimize risks.

  • Effective PV can improve pub...read more

Q6. What is causality

Ans.

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

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Q7. What is Medra

Ans.

Medra is a medical dictionary used for coding adverse events and medication errors in clinical trials and post-marketing surveillance.

  • Medra stands for Medical Dictionary for Regulatory Activities

  • It is a standardized medical terminology used for coding adverse events and medication errors in clinical trials and post-marketing surveillance

  • It is maintained by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

  • It includes ...read more

Q8. What is ICH

Ans.

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

Q9. 1.what is pv?

Ans.

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

Q10. Define pharmacovigilance

Ans.

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

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