10+ Drug Safety Associate 2 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

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.

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

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

An event is coded using a standardized dictionary of terms called MedDRA.

• MedDRA is a hierarchical dictionary with five levels of terms.

• The event is coded to the most specific term available in MedDRA.

• If the event is not listed in MedDRA, it can be coded as 'not otherwise specified' or 'unclassified'.

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 prevent adverse drug reactions (ADRs) and other drug-related issues.

• Pharmacovigilance activities include collecting and analyzing data on drug safety, conducting risk assessments, and implementin...read more

I enjoy hiking and exploring new trails in my free time.

• Hiking is a great way for me to stay active and enjoy nature

• Exploring new trails allows me to discover new places and challenge myself

• I often go hiking with friends or family to make it a social activity

QCr role in PV is to ensure quality control of pharmacovigilance activities to maintain compliance with regulations and standards.

• QCr (Quality Control reviewer) plays a crucial role in reviewing pharmacovigilance documents and reports to ensure accuracy and compliance.

• They verify data accuracy, completeness, and consistency to maintain high quality standards.

• QCr also ensures that pharmacovigilance activities adhere to regulatory requirements and company SOPs.

• Examples of QCr a...read more