Navitas Life Sciences
Zomato Interview Questions and Answers
Q1. How many times medea updates
MedDRA updates occur annually and are released in March.
MedDRA updates are released annually in March
Each update includes new and revised terms
Updates are made based on feedback from users and regulatory authorities
Q2. Submission timelines for adverse events
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.
Q3. Criteria for valid case
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
Q4. What is adverse effect, post marketing and clinical trial
Adverse effects are negative reactions to drugs. Post marketing refers to monitoring after drug approval. Clinical trials are pre-approval studies.
Adverse effects are unwanted or harmful reactions to drugs
Post marketing surveillance is the monitoring of drugs after they have been approved and are on the market
Clinical trials are studies conducted before a drug is approved to determine its safety and efficacy
Adverse effects can be discovered in both post marketing surveillance...read more
Q5. Medea version
The Medea version question is asking about your experience with pharmacovigilance software.
Discuss your familiarity with MedDRA and WHODrug coding systems
Explain your experience with using pharmacovigilance software such as ARISg, Argus, or Empirica
Mention any specific tasks you have performed using these software, such as case processing or signal detection
Highlight any challenges you have faced while using these software and how you overcame them
Q6. Examples of Different regulatory authorities.
Regulatory authorities are organizations responsible for overseeing and enforcing regulations in specific industries.
Food and Drug Administration (FDA) - regulates food and drug products in the United States
Securities and Exchange Commission (SEC) - oversees securities markets and enforces regulations
Federal Communications Commission (FCC) - regulates communications by radio, television, wire, satellite, and cable
Environmental Protection Agency (EPA) - enforces regulations re...read more
Q7. What is the phases of Clinical trial
Clinical trials have four phases that test the safety and effectiveness of a new drug or treatment.
Phase 1: Small group of healthy volunteers to test safety and dosage
Phase 2: Larger group of patients to test effectiveness and side effects
Phase 3: Even larger group of patients to confirm effectiveness, monitor side effects, and compare to existing treatments
Phase 4: Post-marketing surveillance to monitor long-term safety and effectiveness in larger population
Q8. What is Pharmacovigilance
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 and evaluating the safety of pharmaceutical products.
It aims to identify and assess adverse drug reactions (ADRs) and other drug-related issues.
Pharmacovigilance activities include collecting and analyzing data from healthcare professionals, patients, and regulatory autho...read more
Interview Process at Zomato
Top Interview Questions from Similar Companies
Reviews
Interviews
Salaries
Users/Month