50+ Parexel International Interview Questions and Answers

MedDRA is a medical terminology used for coding adverse events. Its current version is 23.1.

• MedDRA stands for Medical Dictionary for Regulatory Activities

• It is used for coding and classifying adverse events in clinical trials and post-marketing surveillance

• The current version of MedDRA is 23.1

• ADR stands for Adverse Drug Reaction, which is any harmful or unintended reaction to a drug

• AE stands for Adverse Event, which is any untoward medical occurrence in a patient

• The main diff...read more

Yes, I plan to pursue a Master's degree in Pharmacology.

• I have always been interested in the pharmacological aspect of drug safety.

• A Master's degree in Pharmacology will help me gain a deeper understanding of drug mechanisms and interactions.

• I plan to continue working while pursuing my degree part-time.

• I believe this will enhance my skills and knowledge as a Drug Safety Associate.

Adverse drug reaction is a harmful or unintended response to a medication, while adverse drug event is any untoward medical occurrence related to drug use.

• Adverse drug reaction is a type of adverse drug event

• Adverse drug reactions are usually dose-dependent

• Adverse drug events can include medication errors, allergic reactions, and drug interactions

• Adverse drug events can occur even when a medication is used correctly

• Adverse drug events can range from mild to severe, and can ev...read more

Antimalarial agents are drugs used to treat or prevent malaria.

• Chloroquine

• Mefloquine

• Quinine

• Artemisinin

• Atovaquone-proguanil

• Doxycycline

• Primaquine

This question covers various financial concepts and skills.

• Forecasting involves predicting future financial outcomes based on historical data and trends.

• Budgeting is the process of creating a financial plan for a specific period of time, typically a year.

• Accounting entries are the records of financial transactions that are used to create financial statements.

• Interest rate swaps are financial contracts that allow two parties to exchange interest rate payments.

• Cross currency re...read more

Oral hypoglycemic agents are drugs used to treat type 2 diabetes by lowering blood sugar levels.

• Sulfonylureas - stimulate insulin secretion (e.g. glipizide)

• Biguanides - decrease glucose production in liver (e.g. metformin)

• Alpha-glucosidase inhibitors - slow carbohydrate absorption (e.g. acarbose)

• Thiazolidinediones - increase insulin sensitivity (e.g. pioglitazone)

• Dipeptidyl peptidase-4 inhibitors - increase insulin secretion and decrease glucagon secretion (e.g. sitagliptin)

• S...read more

Diabetes Insipidus is a rare condition caused by a deficiency of antidiuretic hormone, leading to excessive urination and thirst. Diabetes Mellitus is a common condition characterized by high blood sugar levels due to either insufficient insulin production or ineffective use of insulin.

• Diabetes Insipidus is caused by a deficiency of antidiuretic hormone, while Diabetes Mellitus is caused by either insufficient insulin production or ineffective use of insulin.

• Diabetes Insipidu...read more

Rheumatoid arthritis is an autoimmune disease that affects the joints, while gout is a form of arthritis caused by the buildup of uric acid crystals in the joints.

• Rheumatoid arthritis is an autoimmune disease where the immune system attacks the joints, leading to inflammation, pain, and joint damage.

• Gout is a type of arthritis caused by the buildup of uric acid crystals in the joints, resulting in sudden and severe pain, swelling, and redness.

• Rheumatoid arthritis commonly aff...read more

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

• Pharmacovigilance helps in identifying new safety concerns and taking appropriate actions to minimize risks

• Examples of pharmacovigilance activities include si...read more

Diabetes insipidus is a rare condition characterized by excessive thirst and urination due to the inability of the kidneys to properly regulate water balance.

• Diabetes insipidus is caused by a deficiency of antidiuretic hormone (ADH) or a lack of response to ADH.

• There are two main types of diabetes insipidus: central diabetes insipidus and nephrogenic diabetes insipidus.

• Central diabetes insipidus is caused by a problem with the production or release of ADH, while nephrogenic d...read more

SQL is necessary for most projects involving databases to manage and query data efficiently.

• SQL is essential for creating, updating, and querying databases in most projects.

• Without SQL, it would be challenging to interact with databases and retrieve specific data.

• Examples of SQL commands include SELECT, INSERT, UPDATE, and DELETE.

• SQL can help optimize database performance and ensure data integrity.

A trusted business advisor plays a crucial role in providing strategic financial guidance and support to help the organization achieve its goals.

• Provides strategic financial guidance to help the organization achieve its goals

• Offers insights and recommendations based on financial analysis

• Builds strong relationships with key stakeholders to understand their needs and provide tailored solutions

• Acts as a trusted partner in decision-making processes

• Helps in identifying risks and o...read more

Enzymes are biological catalysts that speed up chemical reactions, while hormones are chemical messengers that regulate various bodily functions.

• Enzymes are proteins that catalyze biochemical reactions by lowering the activation energy needed for the reaction to occur.

• Hormones are signaling molecules produced by glands in the endocrine system and are transported through the bloodstream to target cells or organs.

• Enzymes are specific in their action and typically work on a part...read more

Security requirements can be categorized into different types such as confidentiality, integrity, availability, and accountability.

• Confidentiality: protecting sensitive information from unauthorized access

• Integrity: ensuring data is accurate and unaltered

• Availability: ensuring systems and data are accessible when needed

• Accountability: tracking and auditing user actions

• Examples: access control, encryption, firewalls, backups

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 an event can cause another event to occur.

• It involves identifying a relationship between a potential cause and an observed effect.

• Causality can be established through various methods, including randomized controlled trials and observational studies.

• For example, smoking is a known cause of lung cancer...read more

Neurotransmitters are chemical messengers that transmit signals across synapses between neurons in the brain and nervous system.

• Neurotransmitters are released from the axon terminal of one neuron and bind to receptors on the dendrites of another neuron.

• Examples of neurotransmitters include serotonin, dopamine, and acetylcholine.

• They play a crucial role in regulating various functions such as mood, memory, sleep, and muscle movement.

Metformin works by decreasing glucose production in the liver and increasing insulin sensitivity in the body.

• Metformin reduces glucose production in the liver

• It increases insulin sensitivity in the body

• It also improves glucose uptake and utilization in the muscles

• Metformin activates AMP-activated protein kinase (AMPK) which regulates energy metabolism

• It also inhibits complex I of the mitochondrial respiratory chain, leading to decreased ATP production and increased glucose up...read more

Causality refers to the relationship between a cause and its effect, determining if one event directly led to another.

• Causality is the principle that one event is the result of the occurrence of another event

• It involves determining if there is a direct relationship between a specific cause and its effect

• In drug safety, causality assessment is used to determine if a drug is responsible for an adverse event

• Factors like timing, dose-response relationship, and alternative explana...read more

TB is caused by Mycobacterium tuberculosis and has four stages: exposure, latent infection, active TB disease, and drug-resistant TB.

• TB is caused by the bacterium Mycobacterium tuberculosis.

• The four stages of TB are exposure, latent infection, active TB disease, and drug-resistant TB.

• Exposure occurs when a person inhales the TB bacteria.

• Latent infection is when the bacteria are present in the body but not causing symptoms.

• Active TB disease occurs when the bacteria multiply an...read more

GCP ICH Guidelines are international standards for designing, conducting, recording, and reporting clinical trials.

• GCP stands for Good Clinical Practice, which ensures the protection of human subjects and the reliability of trial results.

• ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

• The guidelines provide a unified standard for the European Union, Japan, and the United States.

• They cover aspects such as ethic...read more

Documents submitted for approval include technical reports, clinical trial data, labeling, and manufacturing information.

• Technical reports

• Clinical trial data

• Labeling

• Manufacturing information

Antimicrobial drugs are medications used to treat infections caused by bacteria, fungi, viruses, or parasites.

• Antimicrobial drugs target specific components of microorganisms to inhibit their growth or kill them.

• Examples include antibiotics (e.g. penicillin), antifungals (e.g. fluconazole), antivirals (e.g. acyclovir), and antiparasitics (e.g. metronidazole).

• Mechanisms of action include disrupting cell wall synthesis, inhibiting protein synthesis, interfering with DNA replica...read more

Cross joins are a type of join operation in SQL that combines each row from one table with each row from another table.

• Cross joins do not have a join condition specified, resulting in a Cartesian product of the two tables.

• They can be used when you want to combine every row from one table with every row from another table.

• Cross joins can lead to a large result set if the tables being joined have many rows.

An agile story is a user-centric description of a feature or functionality that provides value to the end user.

• Agile stories are used in Agile software development to capture user requirements.

• They are typically written in a specific format, such as 'As a [user role], I want [feature] so that [benefit]'.

• Agile stories are often written on index cards or in a digital tool called a backlog.

• They serve as a communication tool between the development team and stakeholders.

• Examples ...read more

Half life of a drug refers to the time taken for the concentration of the drug in the body to reduce by half.

• Half life is important in determining the dosing frequency of a drug.

• It is influenced by factors such as metabolism and excretion of the drug.

• Examples of drugs with short half-lives include morphine and fentanyl, while drugs with long half-lives include diazepam and fluoxetine.

Authorities responsible for drug safety regulations and approvals

• Food and Drug Administration (FDA) in the US

• European Medicines Agency (EMA) in Europe

• Pharmaceuticals and Medical Devices Agency (PMDA) in Japan

• Health Canada in Canada

• Therapeutic Goods Administration (TGA) in Australia

HQL stands for Hibernate Query Language, a query language similar to SQL but used for Hibernate ORM framework.

• HQL is used to perform database operations in Hibernate ORM framework.

• It is similar to SQL but operates on Hibernate objects instead of database tables.

• HQL queries are written in Hibernate-specific syntax.

• Example: 'FROM Employee e WHERE e.department = :dept'

• HQL queries are translated into SQL queries by Hibernate at runtime.

Views in Java are user interface components that display data from a model in a specific format.

• Views are used to represent the user interface in Java applications.

• They display data from a model in a visually appealing format.

• Examples include buttons, text fields, labels, and checkboxes.

Delete removes rows one by one, while truncate removes all rows at once.

• Delete is a DML command, while truncate is a DDL command.

• Delete can be rolled back, while truncate cannot be rolled back.

• Delete fires triggers, while truncate does not fire triggers.

• Delete is slower as it logs individual row deletions, while truncate is faster as it logs the deallocation of the data pages.

A data model for master data defines the structure and relationships of core business data.

• It includes entities such as customers, products, and suppliers.

• It ensures consistency and accuracy of data across the organization.

• It may use a hierarchical or relational structure.

• It is often used in data governance and data management initiatives.

Hypertension is a medical condition characterized by high blood pressure.

• Hypertension is often referred to as the 'silent killer' because it usually has no symptoms but can lead to serious health issues.

• It is diagnosed when blood pressure consistently measures 130/80 mm Hg or higher.

• Risk factors for hypertension include obesity, lack of physical activity, high salt intake, and genetics.

• Complications of hypertension can include heart disease, stroke, kidney damage, and vision ...read more

Antimicrobial agents are substances that kill or inhibit the growth of microorganisms such as bacteria, viruses, fungi, or parasites.

• Antimicrobial agents can be classified into antibiotics, antivirals, antifungals, and antiparasitics.

• Examples of antimicrobial agents include penicillin (antibiotic), acyclovir (antiviral), fluconazole (antifungal), and ivermectin (antiparasitic).

• They are used to treat infections caused by various microorganisms.

• Antimicrobial resistance is a gro...read more

Alzheimer's disease is a progressive neurodegenerative disorder that affects memory, thinking, and behavior.

• Characterized by the formation of amyloid plaques and neurofibrillary tangles in the brain

• Symptoms include memory loss, confusion, disorientation, and behavioral changes

• No cure currently exists, but treatments can help manage symptoms and improve quality of life

Tablets are solid dosage forms that contain API and excipients. They can be classified based on disintegration, pH, dissolution, and vitamins.

• API refers to the active pharmaceutical ingredient in the tablet.

• Excipients are inactive substances that help in the formation and stability of the tablet.

• Disintegration is the process by which the tablet breaks down into smaller particles in the stomach.

• pH affects the solubility and stability of the tablet.

• Dissolution is the process by...read more

Drugs used in myocardial infarction (MI) include antiplatelet agents, beta blockers, ACE inhibitors, and statins.

• Antiplatelet agents such as aspirin and clopidogrel are used to prevent blood clots

• Beta blockers like metoprolol help reduce heart rate and blood pressure

• ACE inhibitors like lisinopril help improve heart function and reduce strain on the heart

• Statins like atorvastatin are used to lower cholesterol levels and reduce the risk of further heart problems

Allergens are substances that can cause an allergic reaction in the body.

• Allergens are typically harmless substances that trigger an immune response in sensitive individuals.

• Common allergens include pollen, dust mites, pet dander, certain foods, and insect venom.

• Exposure to allergens can lead to symptoms such as sneezing, itching, hives, and difficulty breathing.

• Allergens can be found in various environments, including indoor and outdoor settings.

Vaccines are biological preparations that provide active acquired immunity to a particular disease.

• Vaccines contain weakened or killed forms of a microorganism, its toxins, or surface proteins

• They stimulate the immune system to recognize and destroy the specific pathogen

• Vaccines help prevent infectious diseases such as measles, polio, and influenza

Insert and select data in MySQL using SQL queries

• Use INSERT INTO table_name (column1, column2, ...) VALUES (value1, value2, ...); to insert data

• Use SELECT * FROM table_name; to select all data from a table

• Use SELECT column1, column2 FROM table_name WHERE condition; to select specific data based on a condition

Dimensional modeling is a data modeling technique used in data warehousing to organize and structure data for easy analysis and reporting.

• Dimensional modeling focuses on organizing data into dimensions and facts.

• Dimensions represent the descriptive attributes of the data, such as time, location, or product.

• Facts are the measurable numeric values associated with dimensions, such as sales or revenue.

• It uses a star schema or snowflake schema to create a simplified and denormaliz...read more

Anti-hypertensive drugs are used to lower high blood pressure, while diabetes drugs are used to manage blood sugar levels in diabetic patients.

• Anti-hypertensive drugs work by relaxing blood vessels and reducing the workload on the heart.

• There are several classes of anti-hypertensive drugs, including ACE inhibitors, beta blockers, calcium channel blockers, and diuretics.

• Diabetes drugs can be classified into several categories, including insulin, sulfonylureas, biguanides, and ...read more

Causality types in pharmacovigilance

• Certain

• Probable/likely

• Possible

• Unlikely

• Conditional

• Unknown

• Alternative

• Concomitant

• Coincidental

AD stands for Active Directory, SLA stands for Service Level Agreement, and MS Office troubleshooting involves resolving issues with Microsoft Office applications.

• AD (Active Directory) is a directory service used by organizations to manage network resources and users.

• SLA (Service Level Agreement) is a contract between a service provider and a customer that defines the level of service expected.

• MS Office troubleshooting involves identifying and resolving issues with Microsoft ...read more

Regulatory affairs involves ensuring compliance with laws and regulations in various industries.

• Regulatory affairs professionals work to ensure that products and services meet legal and regulatory requirements.

• They may be involved in obtaining approvals for new products or maintaining compliance for existing ones.

• Examples of industries that require regulatory affairs expertise include pharmaceuticals, medical devices, food and beverages, and cosmetics.

• Regulatory affairs profe...read more

CDM is a process of organizing and standardizing healthcare data for analysis and research.

• CDM stands for Clinical Data Management

• It involves collecting, cleaning, and organizing data from various sources

• CDM ensures data quality and consistency

• It is used in clinical trials, healthcare research, and population health management

• Examples of CDM tools include Oracle Clinical, Medidata Rave, and OpenClinica

Cancer drugs work by targeting specific molecules or pathways involved in the growth and spread of cancer cells.

• Cancer drugs can inhibit the growth of cancer cells by interfering with their DNA replication or protein synthesis.

• Some drugs target specific molecules on the surface of cancer cells, blocking signals that promote their growth.

• Other drugs can stimulate the immune system to recognize and attack cancer cells.

• Chemotherapy drugs work by killing rapidly dividing cells, i...read more

Java program to check if two strings are anagrams

• Create a function that takes two strings as input

• Convert both strings to character arrays and sort them

• Check if the sorted arrays are equal to determine if they are anagrams

GET and POST are HTTP methods used in REST APIs for retrieving and sending data.

• GET method is used to retrieve data from a server

• POST method is used to send data to a server

• GET requests are idempotent, while POST requests are not

• GET requests should only be used for retrieving data, not for modifying data

• Example: GET request to retrieve a list of users - GET /users

• Example: POST request to create a new user - POST /users

Definitions in pharmacovigilance refer to the terms and concepts used in the field of monitoring and assessing the safety of pharmaceutical products.

• Pharmacovigilance: The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Adverse Drug Reaction (ADR): Any response to a drug which is noxious and unintended, including lack of efficacy.

• Signal: Information that suggests a new potentially...read more

Service desk work involves providing technical support and assistance to users within an organization.

• Responding to user inquiries and issues via phone, email, or chat

• Troubleshooting technical problems and providing solutions

• Logging and tracking issues in a ticketing system

• Escalating complex issues to higher level support teams

• Providing timely updates and resolutions to users

• Documenting solutions for future reference

Incident management is the process of identifying, analyzing, and resolving incidents to minimize their impact on business operations.

• Incident management involves logging, categorizing, prioritizing, and escalating incidents

• It aims to restore normal service operation as quickly as possible

• Examples of incidents include network outages, software crashes, and hardware failures

GCP stands for Google Cloud Platform, a suite of cloud computing services offered by Google.

• GCP offers a wide range of services including compute, storage, networking, and machine learning.

• It allows users to build, test, and deploy applications on Google's infrastructure.

• GCP also provides tools for data analytics, security, and management.

• Examples of companies using GCP include Spotify, Coca-Cola, and HSBC.

PV stands for pharmacovigilance, which is the science of monitoring and evaluating the safety and effectiveness of medications.

• PV is a crucial aspect of drug development and post-marketing surveillance.

• It involves collecting, analyzing, and reporting adverse drug reactions and other safety concerns.

• PV helps ensure that medications are safe and effective for patients.

• Examples of PV activities include signal detection, risk management, and regulatory reporting.

ADR ADV stands for Adverse Drug Reaction Advertising and is a regulatory requirement for pharmaceutical companies.

• ADR ADV is a process of reporting adverse drug reactions to regulatory authorities.

• Pharmaceutical companies are required to submit ADR ADV reports to regulatory authorities.

• ADR ADV helps in monitoring the safety and efficacy of drugs.

• Failure to comply with ADR ADV regulations can result in penalties and legal action.

Section 16 PSUR can be sourced from the regulatory authorities or the company's internal database.

• Regulatory authorities like FDA or EMA provide guidelines for PSURs

• Internal database of the company may contain previous PSURs for reference