Synkcode Interview Questions and Answers

Pharmacovigilance is the science of monitoring, evaluating, and preventing adverse effects of drugs.

• Pharmacovigilance involves collecting, analyzing, and reporting adverse drug reactions (ADRs)

• Cases are coded in the database using standardized coding dictionaries such as MedDRA and WHO-DD

• The coding process involves selecting the appropriate terms to describe the ADR and its severity

• The coded data is used for signal detection, risk management, and regulatory reporting

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 was formed in 1990 by regulatory authorities and the pharmaceutical industry.

• ICH guidelines cover topics such as clinical trials, safety, quality, and efficacy.

• The guidelines are not legally binding, but are widely adopted by regulatory authorities around the world.

• Examples o...read more

Regulatory timelines refer to the timeframes set by regulatory agencies for the approval and monitoring of drugs and medical devices.

• Regulatory timelines vary depending on the type of drug or device being reviewed and the regulatory agency involved.

• For example, the FDA has different timelines for new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

• Regulatory timelines can also be affected by factors such as the complexity of the drug or device, the avai...read more

Valid case criteria include identifiable patient, suspect drug, adverse event, and temporal relationship.

• Identifiable patient information

• Suspect drug information

• Adverse event information

• Temporal relationship between drug and event

• Supporting medical documentation

• Exclusion of alternative causes

• Consistency with known drug effects

• Reported by qualified reporter

Yes, I am able to write the narrative.

• I have experience in writing narratives for adverse events and serious adverse events.

• I am familiar with the regulatory requirements for narrative writing.

• I have strong attention to detail and can accurately capture all relevant information.

• I am able to effectively communicate complex medical information in a clear and concise manner.

• I am proficient in using various narrative writing tools and software.

Processing involves reviewing adverse event reports, coding and data entry, signal detection, and submission to regulatory agencies.

• Reviewing adverse event reports for accuracy and completeness

• Coding and data entry of adverse events into safety database

• Performing signal detection to identify potential safety concerns

• Preparing and submitting safety reports to regulatory agencies

• Collaborating with cross-functional teams to ensure timely and accurate processing

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 and efficacy of drugs.

• It includes collecting and analyzing data on adverse drug reactions (ADRs) and other drug-related problems.

• Pharmacovigilance also involves communicating information about drug safety to healthcare professionals and the publi...read more