Credence Resource Management Interview Questions and Answers

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

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.

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

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

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

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

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